The following data is part of a premarket notification filed by Ivacare Corp. with the FDA for Full/semi Electric Home Care Bed.
| Device ID | K925534 |
| 510k Number | K925534 |
| Device Name: | FULL/SEMI ELECTRIC HOME CARE BED |
| Classification | Bed, Ac-powered Adjustable Hospital |
| Applicant | IVACARE CORP. 899 CLEVELAND ST. P.O. BOX 4028 Elyria, OH 44036 |
| Contact | Edward A Kroll |
| Correspondent | Edward A Kroll IVACARE CORP. 899 CLEVELAND ST. P.O. BOX 4028 Elyria, OH 44036 |
| Product Code | FNL |
| CFR Regulation Number | 880.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-02 |
| Decision Date | 1993-05-12 |