The following data is part of a premarket notification filed by Tisport with the FDA for Tisport X And Tisport Xc.
| Device ID | K990555 |
| 510k Number | K990555 |
| Device Name: | TISPORT X AND TISPORT XC |
| Classification | Wheelchair, Mechanical |
| Applicant | TISPORT 1426 EAST THIRD AVE. Kennewick, WA 99337 -9669 |
| Contact | Sandra Gladstone |
| Correspondent | Sandra Gladstone TISPORT 1426 EAST THIRD AVE. Kennewick, WA 99337 -9669 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-22 |
| Decision Date | 1999-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853316008105 | K990555 | 000 |