The following data is part of a premarket notification filed by Health Care Innovations, Inc. with the FDA for Folding Wheelchair.
Device ID | K881452 |
510k Number | K881452 |
Device Name: | FOLDING WHEELCHAIR |
Classification | Wheelchair, Mechanical |
Applicant | HEALTH CARE INNOVATIONS, INC. 129 S. ABBE RD. P.O. BOX 240 Elyria, OH 44035 |
Contact | Ken Murphy |
Correspondent | Ken Murphy HEALTH CARE INNOVATIONS, INC. 129 S. ABBE RD. P.O. BOX 240 Elyria, OH 44035 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-04-06 |
Decision Date | 1988-04-21 |