510(k) K853992
K853992 is an FDA 510(k) premarket notification submitted by Valley Forge Scientific Corp. for the device "VALLEY FORGE SCIEN-TENS UNIT & ACCESS. LEAD WIRE &". The FDA issued a decision of Substantially Equivalent on Feb 21, 1986. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Valley Forge Scientific Corp. has 26 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 21, 1986
- Date Received
- Sep 27, 1985
- 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
- 510(k)