The following data is part of a premarket notification filed by Sunrise Medical, Inc. with the FDA for Quickie Suspension Wheelchair Series Model Xtr.
Device ID | K982989 |
510k Number | K982989 |
Device Name: | QUICKIE SUSPENSION WHEELCHAIR SERIES MODEL XTR |
Classification | Wheelchair, Mechanical |
Applicant | SUNRISE MEDICAL, INC. 7477 EAST DRY CREEK PKWY. Longmont, CO 80503 |
Contact | Rebecca Andersen |
Correspondent | Rebecca Andersen SUNRISE MEDICAL, INC. 7477 EAST DRY CREEK PKWY. Longmont, CO 80503 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-08-26 |
Decision Date | 1998-10-05 |
Summary: | summary |