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 |