The following data is part of a premarket notification filed by Tisport with the FDA for Cross Sport, Rigid Wheelchair.
| Device ID | K990358 |
| 510k Number | K990358 |
| Device Name: | CROSS SPORT, RIGID WHEELCHAIR |
| 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 | 1999-02-05 |
| Decision Date | 1999-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853316008099 | K990358 | 000 |
| 00853316008051 | K990358 | 000 |
| 00853316008044 | K990358 | 000 |
| 00853316008037 | K990358 | 000 |
| 00853316008020 | K990358 | 000 |
| 00853316008013 | K990358 | 000 |
| 00853316008006 | K990358 | 000 |
| 00853316008112 | K990358 | 000 |