K160992 is an FDA 510(k) clearance for the HPM-6000. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by BTL Industries, Inc. (Framingham, US). The FDA issued a Cleared decision on October 21, 2016, 196 days after receiving the submission on April 8, 2016.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K160992 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 2016 |
| Decision Date | October 21, 2016 |
| Days to Decision | 196 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 |