The following data is part of a premarket notification filed by Etac Us, Inc. with the FDA for Swede Elite, Mechanical Wheelchair.
| Device ID | K883275 |
| 510k Number | K883275 |
| Device Name: | SWEDE ELITE, MECHANICAL WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | ETAC US, INC. 2233 WEST MILL RD. Glendale, WI 53209 |
| Contact | Cyndi Elsner |
| Correspondent | Cyndi Elsner ETAC US, INC. 2233 WEST MILL RD. Glendale, WI 53209 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-03 |
| Decision Date | 1988-08-18 |