510(k) K260412
K260412 is an FDA 510(k) premarket notification submitted by Shenzhen Dongdixin Technology Co., Ltd. for the device "TENS 7000 Rechargeable 4 Channel (TENS 7000H)". The FDA issued a decision of Substantially Equivalent on Jun 26, 2026. The device falls under product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter), a Class II device regulated under 21 CFR 882.5890. Shenzhen Dongdixin Technology Co., Ltd. has 26 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 26, 2026
- Date Received
- Feb 9, 2026
- 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
- 510(k)
TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES