The following data is part of a premarket notification filed by Sunrise Medical, Inc. with the FDA for Power Recliner.
Device ID | K944423 |
510k Number | K944423 |
Device Name: | POWER RECLINER |
Classification | Wheelchair, Powered |
Applicant | SUNRISE MEDICAL, INC. 2842 BUSINESS PARK AVE. Fresno, CA 93727 |
Contact | Pat Spink |
Correspondent | Pat Spink SUNRISE MEDICAL, INC. 2842 BUSINESS PARK AVE. Fresno, CA 93727 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-08-31 |
Decision Date | 1994-11-28 |