The following data is part of a premarket notification filed by Sunrise Medical Hhg, Inc. with the FDA for Quickie Rhythm.
Device ID | K083249 |
510k Number | K083249 |
Device Name: | QUICKIE RHYTHM |
Classification | Wheelchair, Powered |
Applicant | SUNRISE MEDICAL HHG, INC. 7477 EAST DRY CREEK PKWY. Longmont, CO 80503 |
Contact | James W Lewis |
Correspondent | James W Lewis SUNRISE MEDICAL HHG, 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 | 2008-11-04 |
Decision Date | 2008-12-23 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05022408052363 | K083249 | 000 |
00016958051971 | K083249 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
QUICKIE RHYTHM 78584156 not registered Dead/Abandoned |
Sunrise Medical HHG Inc. 2005-03-10 |