510(k) K014126
K014126 is an FDA 510(k) premarket notification submitted by Roc Chinese-European Industrial Research Society for the device "SANIDAD HEALTH-UP TENS MP-73725". The FDA issued a decision of Substantially Equivalent on May 3, 2002. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Roc Chinese-European Industrial Research Society has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 3, 2002
- Date Received
- December 17, 2001
- 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