MyoPro 2+

Primary DI
00855846007146
Brand
MyoPro 2+
Company
Myomo, Inc.
Model
Motion W Right - 28461 rev1
Catalog number
28461
Device 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 initiateand complete desired motions.
Published
2021-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HCCDevice, Biofeedback
IQIOrthosis, Limb Brace
IQZHand, External Limb Component, Powered
IREJoint, Elbow, External Limb Component, Powered
OALExercise Equipment, Powered, Emg-Triggered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2
IQIOrthosis, Limb BracePhysical Medicine1
IQZHand, External Limb Component, PoweredPhysical Medicine1
IREJoint, Elbow, External Limb Component, PoweredPhysical Medicine1
OALExercise Equipment, Powered, Emg-TriggeredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855846007146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855846007146008558460071468558460071460855846007146

GMDN Terms#

Term, Definition table
TermDefinition
Elbow/wrist/hand orthosisAn externally applied orthopaedic appliance or apparatus designed to encompass the elbow joint, the wrist joint, and the whole or part of the hand to support, correct, or improve function of the elbow, wrist, and hand through actions such as alignment, hinge-support, or dorsiflexion assistance. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
148053676
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855846007238Mobile Arm Rehabilitation Kit version 2 (MARK2)MARK2 29860MARK2 298602024-10-11
00855846007245MyoPro 2x Assembly KitMotion G Left - 30381 rev1303812024-12-11
00855846007252MyoPro 2x Assembly KitMotion G Right - 30382 rev1303822024-12-11
00855846007214MyoPro 2xMotion G Left - 29857 rev1298572024-09-20
00855846007221MyoPro 2xMotion G Right - 29858 rev1298582024-09-20
00855846007153MyoPro 2+Motion G Left - 28462 rev1284622021-09-14
00855846007160MyoPro 2+Motion G Right - 28463 rev1284632021-09-14
00855846007139MyoPro 2+Motion W Left - 28460 rev1284602021-08-28
00855846007009MyoProMotion G Left - 25736257362017-04-01
00855846007016MyoProMotion G Right - 25740257402017-04-01
00855846007023MyoProMotion W Left - 25738257382017-04-01
00855846007030MyoProMotion W Right - 25742257422017-04-01
00855846007047MyoProMotion E Left - 25744257442017-04-01
00855846007054MyoProMotion E Right - 25746257462017-04-01
00855846007061MyoProMotion E Right - 25909 rev1259092017-04-01
00855846007078MyoProMotion E Left - 25910 rev1259102017-04-01
00855846007085MyoProMotion G Right - 25919 rev1259192017-04-01
00855846007092MyoProMotion G Left - 25920 rev1259202017-04-01
00855846007108MyoProMotion W Right - 25921 rev1259212017-04-01
00855846007115MyoProMotion W Left - 25922 rev1259222017-04-01

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