The following data is part of a premarket notification filed by Sunrise Medical, Inc. with the FDA for Quickie Rhapsody, Mwd Series Ii Power Wheelchair.
Device ID | K062701 |
510k Number | K062701 |
Device Name: | QUICKIE RHAPSODY, MWD SERIES II POWER WHEELCHAIR |
Classification | Wheelchair, Powered |
Applicant | SUNRISE MEDICAL, INC. 7477 EAST DRY CREEK PKWY. Longmont, CO 80503 |
Contact | Joseph E Olsavsky |
Correspondent | Joseph E Olsavsky SUNRISE MEDICAL, INC. 7477 EAST DRY CREEK PKWY. Longmont, CO 80503 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-09-11 |
Decision Date | 2006-09-25 |
Summary: | summary |