Mobile Arm Rehabilitation Kit (MARK) MARK 26215

GUDID 00855846007122

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.

MYOMO, INC.

Elbow/wrist/hand orthosis
Primary Device ID00855846007122
NIH Device Record Key5ec6e9cd-b693-4b01-a685-a7acbb371afc
Commercial Distribution StatusIn Commercial Distribution
Brand NameMobile Arm Rehabilitation Kit (MARK)
Version Model NumberMARK 26215
Catalog NumberMARK 26215
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
GS100855846007122 [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 Date2018-04-30
Device Publish Date2018-03-28

Devices Manufactured by MYOMO, INC.

00855846007245 - MyoPro 2x Assembly Kit2024-12-19 The MyoPro 2x, an upper extremity limb orthosis, is an assistive device that supports a weakened or deformed limb for functional
00855846007252 - MyoPro 2x Assembly Kit2024-12-19 The MyoPro 2x, an upper extremity limb orthosis, is an assistive device that supports a weakened or deformed limb for functional
00855846007214 - MyoPro 2x2024-11-11 The MyoPro 2x, an upper extremity limb orthosis, is an assistive device that supports a weakened or deformed limb for functional
00855846007221 - MyoPro 2x2024-11-11 The MyoPro 2x, an upper extremity limb orthosis, is an assistive device that supports a weakened or deformed limb for functional
00855846007238 - Mobile Arm Rehabilitation Kit version 2 (MARK2)2024-11-11 The Mobile Arm Rehabilitation Kit version 2 (MARK2) is a kit containing two (left and right) MyoPro upper extremity limb orthose
00855846007191 - Mobile Arm Rehabilitation Kit version 2 (MARK2)2024-10-21 The Mobile Arm Rehabilitation Kit version 2 (MARK2) is a kit containing two (left and right) MyoPro upper extremity limb orthose
00855846007177 - MyoPro 2x2024-09-30 The MyoPro 2x, an upper extremity limb orthosis, is an assistive device that supports a weakened or deformed limb for functional
00855846007184 - MyoPro 2x2024-09-30 The MyoPro 2x, an upper extremity limb orthosis, is an assistive device that supports a weakened or deformed limb for functional
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