K260412
- 510(k) number
- K260412
- Device name
- TENS 7000 Rechargeable 4 Channel (TENS 7000H)
- Applicant
- Shenzhen Dongdixin Technology Co., Ltd. CN
- Product code
- NUH — Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Decision date
- 2026-06-26
- Date received
- 2026-02-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K260412
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.