FDA.reportPublic FDA data

MyoPro 2x

Primary DI
00855846007214
Brand
MyoPro 2x
Company
Myomo, Inc.
Model
Motion G Left - 29857 rev1
Catalog number
29857
Device description
The MyoPro 2x, 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 2x 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 2x EMG-control circuit continuously monitors and senses, but does not stimulate, the User’s muscles. The MyoPro 2x 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 2x to assist the User to initiateand complete desired motions.
Published
2024-09-20
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

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855846007214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855846007214008558460072148558460072140855846007214

GMDN Terms#

Term, Definition table
TermDefinition
Psychophysiological biofeedback systemA computerized device assembly designed for analysis and real-time feedback (biofeedback) of a variety of physiological parameters [e.g., heart rate, respiration, skin conductance, skin temperature, range of motion, force output, electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG) data] to assist a patient in developing a degree of conscious control over typically involuntary functions, usually for relaxation training and muscle re-education. It includes multiple pieces of patient monitoring hardware (e.g., electrodes, sensors), computer interface devices, and dedicated software; it is intended to be used with an off-the-shelf computer.

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
00855846007221MyoPro 2xMotion G Right - 29858 rev1298582024-09-20
00855846007146MyoPro 2+Motion W Right - 28461 rev1284612021-09-14
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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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