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MyoPro 2+

FDA UDI

Class II (US FDA UDI)

by Myomo, Inc.

Identity

Trade Name
MyoPro 2+ FDA UDI
Generic Name
Psychophysiological biofeedback system FDA UDI
Device Name
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
Motion W Right - 28461 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
28461 FDA UDI
Primary DI / UDI-DI
00855846007146 FDA UDI
FDA Product Code
HCC FDA UDI
IQI FDA UDI
IRE FDA UDI
IQZ FDA UDI
GMDN Term
Psychophysiological biofeedback system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5050 FDA UDI
890.3475 FDA UDI
890.3420 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Elbow orthosisPsychophysiological biofeedback systemHand orthosis

MyoPro 2+ by Myomo, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hand orthosis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Myomo, Inc.

Sources (1)

  • FDA UDI 4c9977e2-f4de-460b-a91a-b4349befd179 34 fields · synced May 31, 2026