The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Cushion, Whelchar And Flotation.
| Device ID | K915629 |
| 510k Number | K915629 |
| Device Name: | CUSHION, WHELCHAR AND FLOTATION |
| Classification | Components, Wheelchair |
| Applicant | INVACARE CORP. 899 CLEVELAND ST. P.O. BOX 4028 Elyria, OH 44036 |
| Contact | Edward Kroll |
| Correspondent | Edward Kroll INVACARE CORP. 899 CLEVELAND ST. P.O. BOX 4028 Elyria, OH 44036 |
| Product Code | KNN |
| CFR Regulation Number | 890.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-17 |
| Decision Date | 1992-01-09 |