MyoPro
- Primary DI
- 00855846007061
- Brand
- MyoPro
- Company
- Myomo, Inc.
- Model
- Motion E Right - 25909 rev1
- Catalog number
- 25909
- Device description
- The MyoPro, 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 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 multi-articulating wrist (MAW), a static hand orthosis or powered hand orthosis with EMG sensors, and an interchangeable battery with a separate recharging station.The MyoPro’s EMG-control circuit continuously monitors and senses, but does not stimulate, the User’s muscles. The MyoPro 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 initiateand complete desired motions.
- Published
- 2017-04-01
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
Product Codes#
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HCC | Device, Biofeedback | Neurology | 2 |
| IQI | Orthosis, Limb Brace | Physical Medicine | 1 |
| IQZ | Hand, External Limb Component, Powered | Physical Medicine | 1 |
| IRE | Joint, Elbow, External Limb Component, Powered | Physical Medicine | 1 |
| OAL | Exercise Equipment, Powered, Emg-Triggered | Physical Medicine | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00855846007061 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00855846007061 | 00855846007061 | 855846007061 | 0855846007061 |
GMDN Terms#
| Term | Definition |
|---|---|
| Elbow/wrist/hand orthosis | An 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, align, prevent, or correct deformities/injuries or to improve function of the elbow, wrist, and hand. This is a reusable device. |
Sterilization Methods#
| 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 | Catalog | Published |
|---|---|---|---|---|
| 00855846007238 | Mobile Arm Rehabilitation Kit version 2 (MARK2) | MARK2 29860 | MARK2 29860 | 2024-10-11 |
| 00855846007245 | MyoPro 2x Assembly Kit | Motion G Left - 30381 rev1 | 30381 | 2024-12-11 |
| 00855846007252 | MyoPro 2x Assembly Kit | Motion G Right - 30382 rev1 | 30382 | 2024-12-11 |
| 00855846007214 | MyoPro 2x | Motion G Left - 29857 rev1 | 29857 | 2024-09-20 |
| 00855846007221 | MyoPro 2x | Motion G Right - 29858 rev1 | 29858 | 2024-09-20 |
| 00855846007146 | MyoPro 2+ | Motion W Right - 28461 rev1 | 28461 | 2021-09-14 |
| 00855846007153 | MyoPro 2+ | Motion G Left - 28462 rev1 | 28462 | 2021-09-14 |
| 00855846007160 | MyoPro 2+ | Motion G Right - 28463 rev1 | 28463 | 2021-09-14 |
| 00855846007139 | MyoPro 2+ | Motion W Left - 28460 rev1 | 28460 | 2021-08-28 |
| 00855846007009 | MyoPro | Motion G Left - 25736 | 25736 | 2017-04-01 |
| 00855846007016 | MyoPro | Motion G Right - 25740 | 25740 | 2017-04-01 |
| 00855846007023 | MyoPro | Motion W Left - 25738 | 25738 | 2017-04-01 |
| 00855846007030 | MyoPro | Motion W Right - 25742 | 25742 | 2017-04-01 |
| 00855846007047 | MyoPro | Motion E Left - 25744 | 25744 | 2017-04-01 |
| 00855846007054 | MyoPro | Motion E Right - 25746 | 25746 | 2017-04-01 |
| 00855846007078 | MyoPro | Motion E Left - 25910 rev1 | 25910 | 2017-04-01 |
| 00855846007085 | MyoPro | Motion G Right - 25919 rev1 | 25919 | 2017-04-01 |
| 00855846007092 | MyoPro | Motion G Left - 25920 rev1 | 25920 | 2017-04-01 |
| 00855846007108 | MyoPro | Motion W Right - 25921 rev1 | 25921 | 2017-04-01 |
| 00855846007115 | MyoPro | Motion W Left - 25922 rev1 | 25922 | 2017-04-01 |
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