510(k) K191982
K191982 is an FDA 510(k) premarket notification submitted by Shenzhen Kentro Medical Electronics Co., Ltd. for the device "Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)". The FDA issued a decision of Substantially Equivalent on Sep 25, 2020. The device falls under product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter), a Class II device regulated under 21 CFR 882.5890. Shenzhen Kentro Medical Electronics Co., Ltd. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 25, 2020
- Date Received
- Jul 25, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- NE
- Submission Type
TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES