OAL · Exercise Equipment, Powered, Emg-Triggered
Physical Medicine · 21 CFR 890.1375 · Class 2
Overview
| Product Code | OAL |
|---|---|
| Device Name | Exercise Equipment, Powered, Emg-Triggered |
| Regulation | 21 CFR 890.1375 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
Identification
A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K062631 | MYOMO E100 | Myomo, Inc. | Apr 12, 2007 | SESE |
Top Applicants
- Myomo, Inc. — 1 clearance
