The following data is part of a premarket notification filed by Sunrise Medical with the FDA for Quickie Interchange Fwd W/lift Power Wheelchair.
Device ID | K043435 |
510k Number | K043435 |
Device Name: | QUICKIE INTERCHANGE FWD W/LIFT POWER WHEELCHAIR |
Classification | Wheelchair, Powered |
Applicant | SUNRISE MEDICAL 100 DEVILBISS DR. Somerset, PA 15501 |
Contact | Joseph E Olsavsky |
Correspondent | Joseph E Olsavsky SUNRISE MEDICAL 100 DEVILBISS DR. Somerset, PA 15501 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-12-13 |
Decision Date | 2005-02-11 |
Summary: | summary |