510(k) K041092
K041092 is an FDA 510(k) premarket notification submitted by Vision Quest Industries, Inc. for the device "FAST START TENS, MODEL FS 3001". The FDA issued a decision of Substantially Equivalent on July 1, 2004. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Vision Quest Industries, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 1, 2004
- Date Received
- April 26, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve, Transcutaneous, For Pain Relief
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- NE
- Submission Type