Mobile Arm Rehabilitation Kit version 2 (MARK2)

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 29860Model MyoPro 2+ Motion G Right

by Myomo, Inc.

Identity

Trade Name: MARK2 EUDAMED
Mobile Arm Rehabilitation Kit version 2 (MARK2) FDA UDI
Generic Name: Psychophysiological biofeedback system FDA UDI
Device Name: MyoPro 2+ Motion G Right EUDAMED
The Mobile Arm Rehabilitation Kit version 2 (MARK2) 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 MARK2 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. FDA UDI
Model / Reference: MyoPro 2+ Motion G Right EUDAMED
29860 EUDAMED
MARK2 29860 FDA UDI
Description: The Mobile Arm Rehabilitation Kit version 2 (MARK2) 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 MARK2 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. FDA UDI

Identifiers

Catalog Number: MARK2 29860 FDA UDI
Primary DI / UDI-DI: 00855846007238 EUDAMEDFDA UDI
Basic UDI-DI: 0855846007MyoPro2V4 EUDAMED
FDA Product Code: HCC FDA UDI
IQI FDA UDI
IRE FDA UDI
IQZ FDA UDI
EMDN Code: Y061899 UPPER EXTREMITY PROSTHESES - OTHER EUDAMED
GMDN Term: Psychophysiological biofeedback system FDA UDI

Classification

Device Class: Class I EUDAMED
Class II FDA UDI
Regulation Number: 882.5050 FDA UDI
890.3475 FDA UDI
890.3420 FDA UDI
Market of Registration: Ireland EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Elbow orthosis Psychophysiological biofeedback system Hand orthosis

Mobile Arm Rehabilitation Kit version 2 (MARK2) by Myomo, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Myomo, Inc.

Sources (2)

FDA UDI 39715f2b-84fb-45df-a0bf-bb922f195be9 34 fields · synced Aug 2, 2026
EUDAMED a3090e1d-2e7d-4a58-960d-b6b3b3c8068c 61 fields · synced Aug 2, 2026