The following data is part of a premarket notification filed by Sunrise Medical, Inc. with the FDA for Quickie P100 Series, Quickie P200 Series, Quickie P300 Series, Models P100,p110,p120,p190,p190r,p500,p200,p210,p320,p300.
| Device ID | K981462 |
| 510k Number | K981462 |
| Device Name: | QUICKIE P100 SERIES, QUICKIE P200 SERIES, QUICKIE P300 SERIES, MODELS P100,P110,P120,P190,P190R,P500,P200,P210,P320,P300 |
| Classification | Wheelchair, Powered |
| Applicant | SUNRISE MEDICAL, INC. 7477A EAST DRY CREEK PKWY. Longmont, CO 80503 |
| Contact | Rebecca Andersen |
| Correspondent | Rebecca Andersen SUNRISE MEDICAL, INC. 7477A EAST DRY CREEK PKWY. Longmont, CO 80503 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-23 |
| Decision Date | 1998-11-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05022408043415 | K981462 | 000 |
| 00016958043419 | K981462 | 000 |