510(k) K182671
K182671 is an FDA 510(k) premarket notification submitted by Jkh USA, LLC for the device "Medi-Direct TENS Pen". The FDA issued a decision of Substantially Equivalent on September 21, 2019. The device falls under product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter), a Class II device regulated under 21 CFR 882.5890. Jkh USA, LLC has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 21, 2019
- Date Received
- September 26, 2018
- 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