TENS 7000 Rechargeable 4 Channel (TENS 7000H)— 510(k) K260412
Substantially EquivalentShenzhen Dongdixin Technology Co., Ltd.
FDA 510(k) clearance K260412 for TENS 7000 Rechargeable 4 Channel (TENS 7000H), Substantially Equivalent on 2026-06-26. Applicant: Shenzhen Dongdixin Technology Co., Ltd.. Device class: 2.
Summary
Shenzhen Dongdixin Technology's TENS 7000 Rechargeable 4 Channel (model TENS 7000H) is filed under NUH, over-the-counter transcutaneous nerve stimulators. The rechargeable and four-channel details come from the device name.
Class II, 21 CFR 882.5890. Neurology is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Dongdixin filed from Shenzhen, China. The decision came 137 calendar days after receipt (February 9 to June 26, 2026).
Clearance details
- Applicant
- Shenzhen Dongdixin Technology Co., Ltd.
- Product code
- Product code NUH
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
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