The following data is part of a premarket notification filed by Etac Sverige Ab with the FDA for Balder Finesse And Junior Powered Wheelchairs (with Stand-up Option).
| Device ID | K072475 |
| 510k Number | K072475 |
| Device Name: | BALDER FINESSE AND JUNIOR POWERED WHEELCHAIRS (WITH STAND-UP OPTION) |
| Classification | Wheelchair, Standup |
| Applicant | ETAC SVERIGE AB 1705 CAPITAL OF TEXAS HIGHWAY SUITE 500 Austin, TX 78746 |
| Contact | Ian Gordon |
| Correspondent | Ian Gordon ETAC SVERIGE AB 1705 CAPITAL OF TEXAS HIGHWAY SUITE 500 Austin, TX 78746 |
| Product Code | IPL |
| CFR Regulation Number | 890.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-04 |
| Decision Date | 2007-12-21 |
| Summary: | summary |