The following data is part of a premarket notification filed by Dignicare with the FDA for Wheelchair Cushions.
Device ID | K851814 |
510k Number | K851814 |
Device Name: | WHEELCHAIR CUSHIONS |
Classification | Cushion, Flotation |
Applicant | DIGNICARE 10 WEST STREETSBORO RD. P.O. BOX 1496 Hudson, OH 44236 |
Contact | William Mcgraw |
Correspondent | William Mcgraw DIGNICARE 10 WEST STREETSBORO RD. P.O. BOX 1496 Hudson, OH 44236 |
Product Code | KIC |
CFR Regulation Number | 890.3175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-26 |
Decision Date | 1985-07-09 |