K240234 is an FDA 510(k) clearance for the BTL-899MS. 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 August 17, 2024, 201 days after receiving the submission on January 29, 2024.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K240234 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 2024 |
| Decision Date | August 17, 2024 |
| Days to Decision | 201 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 |