K232937 is an FDA 510(k) clearance for the BTL-899M. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by BTL Industries, Inc. (Marlborough, US). The FDA issued a Cleared decision on December 26, 2023, 97 days after receiving the submission on September 20, 2023.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K232937 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 2023 |
| Decision Date | December 26, 2023 |
| Days to Decision | 97 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 |