The following data is part of a premarket notification filed by Vision Quest Industries, Inc. with the FDA for T.e.a.r. Tech3.
| Device ID | K090532 |
| 510k Number | K090532 |
| Device Name: | T.E.A.R. TECH3 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | VISION QUEST INDUSTRIES, INC. 18011 MITCHELL SOUTH Irvine, CA 92614 |
| Contact | Wallace Fischer |
| Correspondent | Wallace Fischer VISION QUEST INDUSTRIES, INC. 18011 MITCHELL SOUTH Irvine, CA 92614 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-27 |
| Decision Date | 2009-11-13 |
| Summary: | summary |