Identifiers
- 510(k) Number
- K062631 FDA 510(k)
- FDA Product Code
- OAL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.1375 FDA 510(k)
- Regulation Number
- 890.1375 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Myomo E100 is an electromechanically powered elbow brace that facilitates movement and range of motion. It is used for stroke rehabilitation by muscle re-education and to maintain or increase range of motion. The device is classified as Exercise Equipment, Powered, Emg-Triggered, and is used in the field of Physical Medicine.
The Myomo E100 is supplied as a single device and is intended for use in physical therapy settings. It is designed to facilitate arm movement and increase range of motion for stroke patients undergoing rehabilitation. The device has received FDA 510(k) clearance and is classified under regulation number 890.1375.
Frequently asked questions
What is the Myomo E100 used for?
The Myomo E100 is used for stroke rehabilitation by muscle re-education and to maintain or increase range of motion, facilitating arm movement and increasing range of motion for stroke patients.
How is the Myomo E100 supplied?
The Myomo E100 is supplied as a single device, intended for use in physical therapy settings.
Is the Myomo E100 cleared by the FDA?
Yes, the Myomo E100 has received FDA 510(k) clearance, classified under regulation number 890.1375 as Exercise Equipment, Powered, Emg-Triggered.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MYOMO E100 (K062631) — FDA 510(k) | Innolitics, Robotic-assisted Rehabilitation of the Extremities, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K062631 | Class II | Active |
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Manufacturer
- Manufacturer
- Myomo, Inc.
Sources (1)
- FDA 510(k) K062631 24 fields · synced Sep 26, 2026