The following data is part of a premarket notification filed by Maddak, Inc. with the FDA for Therapy Gyroscope.
| Device ID | K790528 |
| 510k Number | K790528 |
| Device Name: | THERAPY GYROSCOPE |
| Classification | Board, Scooter, Prone |
| Applicant | MADDAK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KNL |
| CFR Regulation Number | 890.5370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-03-15 |
| Decision Date | 1979-04-03 |