SDX — Neuromuscular Stimulator And Exercise Evaluation System Class II
FDA product code SDX covers "Neuromuscular Stimulator And Exercise Evaluation System", a Class II medical device regulated under 21 CFR 882.1871. Submissions are reviewed by the Neurology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SDX
- Device Class
- Class II
- Regulation Number
- 882.1871
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Definition
A neuromuscular stimulator and evaluation system is a device that applies neuromuscular stimulation and measures a neuromuscular response, for the purpose of evaluating exercise capacity and performance or informing athletic training decisions.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN230051 | myocene | Myocene | January 17, 2025 |