MyoPro 2+ 28462

GUDID 00855846007153

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.

Myomo, Inc.

Elbow/wrist/hand orthosis
Primary Device ID00855846007153
NIH Device Record Keyd21984e2-6838-4dfa-b2c9-d2644d14699e
Commercial Distribution StatusIn Commercial Distribution
Brand NameMyoPro 2+
Version Model NumberMotion G Left - 28462 rev1
Catalog Number28462
Company DUNS148053676
Company NameMyomo, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100855846007153 [Primary]

FDA Product Code

HCCDevice, Biofeedback
OALExercise Equipment, Powered, Emg-Triggered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-22
Device Publish Date2021-09-14

On-Brand Devices [MyoPro 2+]

00855846007139The MyoPro 2+, an upper extremity limb orthosis, is an assistive device that supports a weakened
00855846007160The MyoPro 2+, an upper extremity limb orthosis, is an assistive device that supports a weakened
00855846007153The MyoPro 2+, an upper extremity limb orthosis, is an assistive device that supports a weakened
00855846007146The MyoPro 2+, an upper extremity limb orthosis, is an assistive device that supports a weakened

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