The following data is part of a premarket notification filed by Sunrise Medical Quickie Designs, Inc. with the FDA for Zippie 3 Ts/sp Wheelchair/stander.
Device ID | K920463 |
510k Number | K920463 |
Device Name: | ZIPPIE 3 TS/SP WHEELCHAIR/STANDER |
Classification | Wheelchair, Standup |
Applicant | SUNRISE MEDICAL QUICKIE DESIGNS, INC. 147 EADY COURT Elyria, OH 44035 |
Contact | Robert Wheland |
Correspondent | Robert Wheland SUNRISE MEDICAL QUICKIE DESIGNS, INC. 147 EADY COURT Elyria, OH 44035 |
Product Code | IPL |
CFR Regulation Number | 890.3900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-01-27 |
Decision Date | 1992-04-02 |