The following data is part of a premarket notification filed by Sunrise Medical, Inc. with the FDA for Breezy Series.
| Device ID | K974820 |
| 510k Number | K974820 |
| Device Name: | BREEZY SERIES |
| Classification | Wheelchair, Mechanical |
| Applicant | SUNRISE MEDICAL, INC. 7477 EAST DRY CREEK PKWY. Longmont, CO 80503 |
| Contact | Rebecca Andersen |
| Correspondent | Rebecca Andersen SUNRISE MEDICAL, INC. 7477 EAST DRY CREEK PKWY. Longmont, CO 80503 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-23 |
| Decision Date | 1998-01-27 |
| Summary: | summary |