The following data is part of a premarket notification filed by Sunrise Medical with the FDA for Quickie Rhythm & Groove Series Power Wheelchairs W/quickie Delphi Controls.
Device ID | K060531 |
510k Number | K060531 |
Device Name: | QUICKIE RHYTHM & GROOVE SERIES POWER WHEELCHAIRS W/QUICKIE DELPHI CONTROLS |
Classification | Wheelchair, Powered |
Applicant | SUNRISE MEDICAL 100 DEVILBISS DR. Somerset, PA 15501 |
Contact | Joseph Olsavsky |
Correspondent | Joseph Olsavsky SUNRISE MEDICAL 100 DEVILBISS DR. Somerset, PA 15501 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-02-28 |
Decision Date | 2006-03-17 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00016958060485 | K060531 | 000 |
00016958059823 | K060531 | 000 |
00016958059793 | K060531 | 000 |
00016958059847 | K060531 | 000 |
00016958058680 | K060531 | 000 |