510(k) K172478
K172478 is an FDA 510(k) premarket notification submitted by Wat Medical Technology (Ningbo) Co., Ltd. for the device "TENS device-EmeTerm, CinvStop". The FDA issued a decision of Substantially Equivalent on April 19, 2018. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Wat Medical Technology (Ningbo) Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 19, 2018
- Date Received
- August 16, 2017
- 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