The following data is part of a premarket notification filed by Jay Medical, Ltd. with the FDA for Jay Cushion.
| Device ID | K834517 |
| 510k Number | K834517 |
| Device Name: | JAY CUSHION |
| Classification | Cushion, Flotation |
| Applicant | JAY MEDICAL, LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KIC |
| CFR Regulation Number | 890.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-21 |
| Decision Date | 1984-01-17 |