The following data is part of a premarket notification filed by Sunrise Medical, Inc. with the FDA for Sunrise Scooter Series, Model Unassigned, 3 Wheel Standard Model, 3 Wheel Mid Range Model, 3 Wheel High End Model, 4 Whe.
| Device ID | K981885 |
| 510k Number | K981885 |
| Device Name: | SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MODEL, 3 WHEEL MID RANGE MODEL, 3 WHEEL HIGH END MODEL, 4 WHE |
| Classification | Vehicle, Motorized 3-wheeled |
| 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 | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-29 |
| Decision Date | 1998-11-12 |
| Summary: | summary |