MyoPro 2+

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 28460Model MyoPro 2+ Motion G Right

by Myomo, Inc.

Identity

Trade Name: MyoPro 2+ Motion W Left EUDAMED
MyoPro 2+ FDA UDI
Generic Name: Psychophysiological biofeedback system FDA UDI
Device Name: MyoPro 2+ Motion G Right EUDAMED
The MyoPro 2+, an 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 MyoPro 2+ consists of a combination of the following components: a shoulder harness, a custom-made upper limb orthosis (brace), a powered elbow orthosis with surface electromyography (EMG) sensors, a static or manually set wrist module, a static hand orthosis or powered hand orthosis with EMG sensors, and an interchangeable battery with a separate recharging station. The MyoPro 2+ EMG-control circuit continuously monitors and senses, but does not stimulate, the User’s muscles. The MyoPro 2+ 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 2+ to assist the User to initiate and complete desired motions. FDA UDI
Model / Reference: MyoPro 2+ Motion G Right EUDAMED
28460 EUDAMED
Motion W Left - 28460 rev1 FDA UDI
Description: The MyoPro 2+, an 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 MyoPro 2+ consists of a combination of the following components: a shoulder harness, a custom-made upper limb orthosis (brace), a powered elbow orthosis with surface electromyography (EMG) sensors, a static or manually set wrist module, a static hand orthosis or powered hand orthosis with EMG sensors, and an interchangeable battery with a separate recharging station. The MyoPro 2+ EMG-control circuit continuously monitors and senses, but does not stimulate, the User’s muscles. The MyoPro 2+ 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 2+ to assist the User to initiate and complete desired motions. FDA UDI

Identifiers

Catalog Number: 28460 FDA UDI
Primary DI / UDI-DI: 00855846007139 EUDAMEDFDA UDI
Basic UDI-DI: 0855846007MyoPro2V4 EUDAMED
FDA Product Code: HCC FDA UDI
IQI FDA UDI
IRE FDA UDI
IQZ FDA UDI
EMDN Code: Y060699 ORTHOSES, UPPER EXTREMITY - 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

MyoPro 2+ 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 e25fd383-287f-4fe1-9ad6-9041f6abb679 34 fields · synced Jul 13, 2026
EUDAMED a6519d2d-8446-44f3-aa4a-edf5d390e0d4 61 fields · synced Jul 13, 2026