The following data is part of a premarket notification filed by Sunrise Medical, Inc. with the FDA for Zippie Gs, Model # Eizgs.
| Device ID | K983639 |
| 510k Number | K983639 |
| Device Name: | ZIPPIE GS, MODEL # EIZGS |
| Classification | Wheelchair, Mechanical |
| 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 | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-16 |
| Decision Date | 1998-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00016958099126 | K983639 | 000 |
| 00016958045918 | K983639 | 000 |