The following data is part of a premarket notification filed by Jay Medical, Ltd. with the FDA for Maximus Cushion.
| Device ID | K855072 |
| 510k Number | K855072 |
| Device Name: | MAXIMUS CUSHION |
| Classification | Cushion, Flotation |
| Applicant | JAY MEDICAL, LTD. 805 WALNUT Boulder, CO 80302 |
| Contact | Eric Jay |
| Correspondent | Eric Jay JAY MEDICAL, LTD. 805 WALNUT Boulder, CO 80302 |
| Product Code | KIC |
| CFR Regulation Number | 890.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-19 |
| Decision Date | 1986-03-10 |