The following data is part of a premarket notification filed by Panthera Production Ab with the FDA for Panthera Mechanical Wheelchair, Models S2, U2, Bambino, Micro, Bt.
| Device ID | K083231 |
| 510k Number | K083231 |
| Device Name: | PANTHERA MECHANICAL WHEELCHAIR, MODELS S2, U2, BAMBINO, MICRO, BT |
| Classification | Wheelchair, Mechanical |
| Applicant | PANTHERA PRODUCTION AB 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746 |
| Contact | Stuart R Goldman |
| Correspondent | Stuart R Goldman PANTHERA PRODUCTION AB 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-03 |
| Decision Date | 2009-01-26 |
| Summary: | summary |