The following data is part of a premarket notification filed by Vestil Manufacturing Corp. with the FDA for Extreme 4x4-x8 Power Wheelchair.
| Device ID | K090350 |
| 510k Number | K090350 |
| Device Name: | EXTREME 4X4-X8 POWER WHEELCHAIR |
| Classification | Wheelchair, Powered |
| Applicant | VESTIL MANUFACTURING CORP. 201 GROWTH PKWY. Angola, IN 46703 |
| Contact | Rick Michael |
| Correspondent | Rick Michael VESTIL MANUFACTURING CORP. 201 GROWTH PKWY. Angola, IN 46703 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-11 |
| Decision Date | 2009-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B391X80 | K090350 | 000 |
| 09356399000048 | K090350 | 000 |