K232786 is an FDA 510(k) clearance for the Stimulation System (PA series, PR series, S series and Q series). This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on May 16, 2024, 248 days after receiving the submission on September 11, 2023.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K232786 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 2023 |
| Decision Date | May 16, 2024 |
| Days to Decision | 248 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IPF — Stimulator, Muscle, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5850 |