TENS 7000 Rechargeable 4 Channel (TENS 7000H)— 510(k) K260412

Name: FDA 510(k) clearance K260412
Creator: U.S. Food and Drug Administration
Published: 2026-06-26

Substantially Equivalent

Shenzhen 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.

Clearance details

Applicant: Shenzhen Dongdixin Technology Co., Ltd.
Product code: Code NUH
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2026-02-09
Decision date: 2026-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code NUH

view all

K260425 — TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)2026-06-16
K253896 — TENS/EMS device (GUSE01)2026-03-04
K253305 — TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)2025-12-31
K251958 — VEINOPLUS Back2025-12-23
K253740 — TENS&EMS (HZ9151B, HZ9151C, HZ9151D)2025-12-23

More clearances from Shenzhen Dongdixin Technology Co., Ltd.

view all

K240358 — ShockPhysio Mobile (model SW3200 Basic)2024-06-05
K213043 — Levator Elite (Model LE9011)2022-02-25
K210364 — Migraine Tens Digital Pain Reliever2021-06-17
K180331 — Wireless Pain Relieve Device2018-06-22
K171430 — Incontinence Treatment Device, Model LT20612018-03-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.