Regulatory Open Forum

Hi all, 

We are a medical device company that produces exoskeletons for patients with lower limbs impairments. Our R&D team is working on the design of a manually operated chair with wheels that can be used for two purposes:

• as a starting point for the exoskeleton (and the patient inside it) to stand-up at the beginning of a session. The patient is installed in the exoskeleton in seated position. Chairs need to meet specific requirements in terms of weight to be hold (patient + device),  height, width, etc. and today we did not manage to find one that suits well our needs and that we can recommend to clients.
• to transport the exoskeleton (without the patient) in the rehab center from one room to another (similar to a cart).

We see this chair like a piece of furniture and not a medical device nor an accessory to a medical device. Please note that the chair should not be confused with a wheelchair and we don't intend to use it to aid the locomotion of the patient. The presence of wheels has the only purpose of make the chair more manageable and to facilitate the transport of the medical device (the exoskeleton) across the rehab facility.

I am struggling to find info on how to classify this device both for US and EU, whether we should apply specific regulations in US or directives in EU or specific standards. We currently hold a 510k and CE mark under MDR for the device.

Any comment or insight would be highly appreciated.

Thanks in advance

Maria

I can see parts of IEC 60601-1 or AAMI ES 60601-1, like the applicable mechanical tests that may apply to this chair:

Mobile equipment provided with wheel locks or braking system - test requirements 9.4.3.1 in transport position & 9.4.3.2 excluding transport position

Dynamic forces due to loading from persons (like on a seat with the exoskeleton in your case) per 9.8.3.3

There could be other mechanical hazards based on clause 9, (also refer to table 19) which will help figure out if other mechanical hazards may apply.

Also, there is the standard IEC 80601-2-78 on medical robots for rehabilitation, assessment, compensation or alleviation.  Refer to section 201.9.8 on Mechanical Hazards associated with support systems and see if any of those requirements may apply or are appropriate for your device.

Hi all, 

We are a medical device company that produces exoskeletons for patients with lower limbs impairments. Our R&D team is working on the design of a manually operated chair with wheels that can be used for two purposes:

• as a starting point for the exoskeleton (and the patient inside it) to stand-up at the beginning of a session. The patient is installed in the exoskeleton in seated position. Chairs need to meet specific requirements in terms of weight to be hold (patient + device),  height, width, etc. and today we did not manage to find one that suits well our needs and that we can recommend to clients.
• to transport the exoskeleton (without the patient) in the rehab center from one room to another (similar to a cart).

We see this chair like a piece of furniture and not a medical device nor an accessory to a medical device. Please note that the chair should not be confused with a wheelchair and we don't intend to use it to aid the locomotion of the patient. The presence of wheels has the only purpose of make the chair more manageable and to facilitate the transport of the medical device (the exoskeleton) across the rehab facility.

I am struggling to find info on how to classify this device both for US and EU, whether we should apply specific regulations in US or directives in EU or specific standards. We currently hold a 510k and CE mark under MDR for the device.

Any comment or insight would be highly appreciated.

Thanks in advance

Maria

Hi all, 

We are a medical device company that produces exoskeletons for patients with lower limbs impairments. Our R&D team is working on the design of a manually operated chair with wheels that can be used for two purposes:

• as a starting point for the exoskeleton (and the patient inside it) to stand-up at the beginning of a session. The patient is installed in the exoskeleton in seated position. Chairs need to meet specific requirements in terms of weight to be hold (patient + device),  height, width, etc. and today we did not manage to find one that suits well our needs and that we can recommend to clients.
• to transport the exoskeleton (without the patient) in the rehab center from one room to another (similar to a cart).

We see this chair like a piece of furniture and not a medical device nor an accessory to a medical device. Please note that the chair should not be confused with a wheelchair and we don't intend to use it to aid the locomotion of the patient. The presence of wheels has the only purpose of make the chair more manageable and to facilitate the transport of the medical device (the exoskeleton) across the rehab facility.

I am struggling to find info on how to classify this device both for US and EU, whether we should apply specific regulations in US or directives in EU or specific standards. We currently hold a 510k and CE mark under MDR for the device.

Any comment or insight would be highly appreciated.

Thanks in advance

Maria

Hi Maria:

You can have physically the same exoskeleton, but the intended use is what will determine whether it is a medical device. For example: if it is intended to help a fit person pick up a heavy weight of box in a warehouse, it is probably not a medical device; if it is intended to help a disabled or physically challenged person do the same task that a fit person could, it is probably a medical device. You need to look carefully at your: intended use, indications, contraindications, warnings, precautions and claims, and compare them against the definition of a medical device in the EU Medical Device Regulation Art. #2 (1) and for the US #201(h)(1) of the Food, Drug, and Cosmetic Act. Once you understand if it is a medical device and why, it should become more routine to classify it and determine regulatory requirements. In summary: it is likely to be about the words you use in your marketing material rather than the physical device.

There is a lot of EU MDCG and US FDA Guidance accessible on or via their websites.

Neil

Hi all, 

We are a medical device company that produces exoskeletons for patients with lower limbs impairments. Our R&D team is working on the design of a manually operated chair with wheels that can be used for two purposes:

• as a starting point for the exoskeleton (and the patient inside it) to stand-up at the beginning of a session. The patient is installed in the exoskeleton in seated position. Chairs need to meet specific requirements in terms of weight to be hold (patient + device),  height, width, etc. and today we did not manage to find one that suits well our needs and that we can recommend to clients.
• to transport the exoskeleton (without the patient) in the rehab center from one room to another (similar to a cart).

We see this chair like a piece of furniture and not a medical device nor an accessory to a medical device. Please note that the chair should not be confused with a wheelchair and we don't intend to use it to aid the locomotion of the patient. The presence of wheels has the only purpose of make the chair more manageable and to facilitate the transport of the medical device (the exoskeleton) across the rehab facility.

I am struggling to find info on how to classify this device both for US and EU, whether we should apply specific regulations in US or directives in EU or specific standards. We currently hold a 510k and CE mark under MDR for the device.

Any comment or insight would be highly appreciated.

Thanks in advance

Maria

Hi all, 

We are a medical device company that produces exoskeletons for patients with lower limbs impairments. Our R&D team is working on the design of a manually operated chair with wheels that can be used for two purposes:

• as a starting point for the exoskeleton (and the patient inside it) to stand-up at the beginning of a session. The patient is installed in the exoskeleton in seated position. Chairs need to meet specific requirements in terms of weight to be hold (patient + device),  height, width, etc. and today we did not manage to find one that suits well our needs and that we can recommend to clients.
• to transport the exoskeleton (without the patient) in the rehab center from one room to another (similar to a cart).

We see this chair like a piece of furniture and not a medical device nor an accessory to a medical device. Please note that the chair should not be confused with a wheelchair and we don't intend to use it to aid the locomotion of the patient. The presence of wheels has the only purpose of make the chair more manageable and to facilitate the transport of the medical device (the exoskeleton) across the rehab facility.

I am struggling to find info on how to classify this device both for US and EU, whether we should apply specific regulations in US or directives in EU or specific standards. We currently hold a 510k and CE mark under MDR for the device.

Any comment or insight would be highly appreciated.

Thanks in advance

Maria

For US, a 513(g) could be submitted to FDA for their feedback on device classification and its associated regulations. The 513(g) current standard fee is $5,961 and for a small business the fee is $2,980. It typically takes 60 days for FDA's response.

For EU, could initiate communication with the notified body (since mentioned hold a CE Marked device), they may be able to provide helpful information or point you in the right direction for classification.

Hi all, 

We are a medical device company that produces exoskeletons for patients with lower limbs impairments. Our R&D team is working on the design of a manually operated chair with wheels that can be used for two purposes:

• as a starting point for the exoskeleton (and the patient inside it) to stand-up at the beginning of a session. The patient is installed in the exoskeleton in seated position. Chairs need to meet specific requirements in terms of weight to be hold (patient + device),  height, width, etc. and today we did not manage to find one that suits well our needs and that we can recommend to clients.
• to transport the exoskeleton (without the patient) in the rehab center from one room to another (similar to a cart).

We see this chair like a piece of furniture and not a medical device nor an accessory to a medical device. Please note that the chair should not be confused with a wheelchair and we don't intend to use it to aid the locomotion of the patient. The presence of wheels has the only purpose of make the chair more manageable and to facilitate the transport of the medical device (the exoskeleton) across the rehab facility.

I am struggling to find info on how to classify this device both for US and EU, whether we should apply specific regulations in US or directives in EU or specific standards. We currently hold a 510k and CE mark under MDR for the device.

Any comment or insight would be highly appreciated.

Thanks in advance

Maria

Hi all, 

We are a medical device company that produces exoskeletons for patients with lower limbs impairments. Our R&D team is working on the design of a manually operated chair with wheels that can be used for two purposes:

• as a starting point for the exoskeleton (and the patient inside it) to stand-up at the beginning of a session. The patient is installed in the exoskeleton in seated position. Chairs need to meet specific requirements in terms of weight to be hold (patient + device),  height, width, etc. and today we did not manage to find one that suits well our needs and that we can recommend to clients.
• to transport the exoskeleton (without the patient) in the rehab center from one room to another (similar to a cart).

We see this chair like a piece of furniture and not a medical device nor an accessory to a medical device. Please note that the chair should not be confused with a wheelchair and we don't intend to use it to aid the locomotion of the patient. The presence of wheels has the only purpose of make the chair more manageable and to facilitate the transport of the medical device (the exoskeleton) across the rehab facility.

I am struggling to find info on how to classify this device both for US and EU, whether we should apply specific regulations in US or directives in EU or specific standards. We currently hold a 510k and CE mark under MDR for the device.

Any comment or insight would be highly appreciated.

Thanks in advance

Maria

Hi all, 

We are a medical device company that produces exoskeletons for patients with lower limbs impairments. Our R&D team is working on the design of a manually operated chair with wheels that can be used for two purposes:

• as a starting point for the exoskeleton (and the patient inside it) to stand-up at the beginning of a session. The patient is installed in the exoskeleton in seated position. Chairs need to meet specific requirements in terms of weight to be hold (patient + device),  height, width, etc. and today we did not manage to find one that suits well our needs and that we can recommend to clients.
• to transport the exoskeleton (without the patient) in the rehab center from one room to another (similar to a cart).

We see this chair like a piece of furniture and not a medical device nor an accessory to a medical device. Please note that the chair should not be confused with a wheelchair and we don't intend to use it to aid the locomotion of the patient. The presence of wheels has the only purpose of make the chair more manageable and to facilitate the transport of the medical device (the exoskeleton) across the rehab facility.

I am struggling to find info on how to classify this device both for US and EU, whether we should apply specific regulations in US or directives in EU or specific standards. We currently hold a 510k and CE mark under MDR for the device.

Any comment or insight would be highly appreciated.

Thanks in advance

Maria