The following data is part of a premarket notification filed by Maddak, Inc. with the FDA for Pedal Exerciser.
| Device ID | K832968 |
| 510k Number | K832968 |
| Device Name: | PEDAL EXERCISER |
| Classification | Exerciser, Non-measuring |
| Applicant | MADDAK, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | ION |
| CFR Regulation Number | 890.5370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-01 |
| Decision Date | 1983-09-29 |