510(k) K030507
K030507 is an FDA 510(k) premarket notification submitted by Vision Quest Industries, Inc. for the device "T.E.A.R. TECH3 MODEL #44TT03". The FDA issued a decision of Substantially Equivalent on May 20, 2003. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Vision Quest Industries, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 2003
- Date Received
- February 19, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Muscle, Powered
- Device Class
- Class II
- Regulation Number
- 890.5850
- Review Panel
- PM
- Submission Type