K790528 is an FDA 510(k) clearance for the THERAPY GYROSCOPE. This device is classified as a Board, Scooter, Prone (Class I - General Controls, product code KNL).
Submitted by Maddak, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 3, 1979, 19 days after receiving the submission on March 15, 1979.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5370.
| 510(k) Number | K790528 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 15, 1979 |
| Decision Date | April 03, 1979 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | KNL — Board, Scooter, Prone |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5370 |