The following data is part of a premarket notification filed by Tisport, Llc with the FDA for Tilite Aero X.
| Device ID | K072311 |
| 510k Number | K072311 |
| Device Name: | TILITE AERO X |
| Classification | Wheelchair, Mechanical |
| Applicant | TISPORT, LLC 1426 EAST THIRD AVE. Kennewick, WA 99337 -9669 |
| Contact | Richard S Forman |
| Correspondent | Richard S Forman TISPORT, LLC 1426 EAST THIRD AVE. Kennewick, WA 99337 -9669 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-17 |
| Decision Date | 2007-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853316008075 | K072311 | 000 |
| 00853316008068 | K072311 | 000 |