Mobile Arm Rehabilitation Kit (Mark)

The Mobile Arm Rehabilitation Kit (MARK) is a kit containing two (left and right) MyoPro upper extremity limb orthoses. A MyoPro upper extremity limb orthosis is an assistive device that…

Registry build 21.09.26

The Mobile Arm Rehabilitation Kit (MARK) is a kit containing two (left and right) MyoPro upper extremity limb orthoses. A MyoPro upper extremity limb orthosis is an assistive device that supports a weakened or deformed limb for functional improvement. The user’s electromyography (EMG) muscle activity is used to voluntarily control the impaired limb. The MARK product consists of a combination of the following components: shoulder harnesses, adjustable limb orthoses (braces), powered elbow orthoses with surface electromyography (EMG) sensors, static or manually set multi-articulating wrists (MAW), static hand orthoses or powered hand orthoses with EMG sensors, an interchangeable battery with a separate recharging station, an MTS chafe with loop for anti-rotation strap, a laptop, and a product carrying case/bag. The MyoPro’s EMG-control circuit continuously monitors and senses, but does not stimulate, the User’s muscles. A MyoPro device filters and processes the EMG signal, and translates this information into motor movement. Based on the User’s needs and abilities, the control parameters are adjusted by the User’s Provider. The power assist moves the motor with speed proportional to User’s exertion. This system enables the MyoPro to assist the User to initiate and complete desired motions.

6manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Guangdong (5), Hebei (1).

Chinese manufacturers registered for FDA product code HCC
Manufacturer City Province Registered as Device types
Shenzhen Dongdixin Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 18
Shenzhen Konmed Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 8
Shenzhen XFT Medical Limited Shenzhen Guangdong Manufacturer 8
ISA Mould Engineering Limted Dongguan Guangdong Contract manufacturer 4
Qinhuangdao Huisianpu Medical Systems Inc. Qinhuangdao Hebei Manufacturer 4
Shuhai Jingwei(Shenzhen) Information Technology Co., Ltd. Shenzhen Guangdong Manufacturer 2

Record

Regulatory record for Mobile Arm Rehabilitation Kit (Mark)
Listed by Myomo, Inc., United States
FDA product code HCC
Device type Device, Biofeedback
Device class Class 2
Regulation 21 CFR 882.5050
Establishment Manufacturer
Premarket notification Exempt
Record published 2018-03-28
Record revised 2025-05-09 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Mobile Arm Rehabilitation Kit (Mark)
Catalogue number Size Status
MARK 26215 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Ultium Noraxon U.S.A., Inc. 23
FlexiCAP Deymed Diagnostic S.R.O. 16
Ondamed Ondamed Inc. 15
MyoPro Myomo, Inc. 12
TeleMyo Noraxon U.S.A., Inc. 12
Recording Cap G1 Deymed Diagnostic S.R.O. 8
HAL for Medical Use Cyberdyne Inc. 8
Disc Electrode 9mm Sn (Tin) Deymed Diagnostic S.R.O. 8
Axon Exsurgo Limited 8
Innara Health Innara Health, Inc. 7
Kangaroo Cardinal Health 200, LLC 7
SX230-1000 EMG Sensor Biometrics Ltd. 6

Showing 12 of 241. All products under Device, Biofeedback

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer