K163091 is an FDA 510(k) clearance for the VibraPEP. This device is classified as a Spirometer, Therapeutic (incentive) (Class II - Special Controls, product code BWF).
Submitted by Medica Holdings, LLC (Lake Oswego, US). The FDA issued a Cleared decision on February 21, 2017, 109 days after receiving the submission on November 4, 2016.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5690.
| 510(k) Number | K163091 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 2016 |
| Decision Date | February 21, 2017 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BWF — Spirometer, Therapeutic (incentive) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5690 |