510(k) K253305
K253305 is an FDA 510(k) premarket notification submitted by Shenzhen Jiantuo Electronics Co., Ltd. for the device "TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)". The FDA issued a decision of Substantially Equivalent on December 31, 2025. The device falls under product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter), a Class II device regulated under 21 CFR 882.5890. Shenzhen Jiantuo Electronics Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 31, 2025
- Date Received
- September 29, 2025
- 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