Mobile Arm Rehabilitation Kit version 2 (MARK2)

Primary DI
00855846007191
Brand
Mobile Arm Rehabilitation Kit version 2 (MARK2)
Company
Myomo, Inc.
Model
MARK2 29860
Catalog number
MARK2 29860
Device description
The Mobile Arm Rehabilitation Kit version 2 (MARK2) 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 MARK2 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.
Published
2024-10-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HCCDevice, Biofeedback

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855846007191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855846007191008558460071918558460071910855846007191

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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

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