K150413 is an FDA 510(k) clearance for the QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Cymedica Orthopedics, Inc. (Scottsdale, US). The FDA issued a Cleared decision on April 2, 2015, 43 days after receiving the submission on February 18, 2015.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K150413 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 2015 |
| Decision Date | April 02, 2015 |
| Days to Decision | 43 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 |