The following data is part of a premarket notification filed by Vision Quest Industries, Inc. with the FDA for T.e.a.r. Tech3 Model #44tt03.
Device ID | K030507 |
510k Number | K030507 |
Device Name: | T.E.A.R. TECH3 MODEL #44TT03 |
Classification | Stimulator, Muscle, Powered |
Applicant | VISION QUEST INDUSTRIES, INC. 18011 MITCHELL SO. Irvine, CA 92614 |
Contact | Alan Wade |
Correspondent | Alan Wade VISION QUEST INDUSTRIES, INC. 18011 MITCHELL SO. 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 | 2003-02-19 |
Decision Date | 2003-05-20 |
Summary: | summary |