The following data is part of a premarket notification filed by Invacare Corporation with the FDA for Tdx Sp2 Power Wheechair.
| Device ID | K141783 |
| 510k Number | K141783 |
| Device Name: | TDX SP2 POWER WHEECHAIR |
| Classification | Wheelchair, Powered |
| Applicant | INVACARE CORPORATION ONE INVACARE WAY, P.O.BOX 4028 Elyria, OH 44036 -4190 |
| Contact | Doug Uelmen |
| Correspondent | Doug Uelmen INVACARE CORPORATION ONE INVACARE WAY, P.O.BOX 4028 Elyria, OH 44036 -4190 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-02 |
| Decision Date | 2015-01-09 |
| Summary: | summary |