TECAR Therapy Device (TC2000, TC2001)— 510(k) K252288

Name: FDA 510(k) clearance K252288
Creator: U.S. Food and Drug Administration
Published: 2026-10-13

Substantially Equivalent

Shenzhen Dongdixin Technology Co., Ltd.

FDA 510(k) clearance K252288 for TECAR Therapy Device (TC2000, TC2001), Substantially Equivalent on 2026-10-13. Applicant: Shenzhen Dongdixin Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Dongdixin Technology Co., Ltd.
Product code: Product code PBX
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2025-07-23
Decision date: 2026-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code PBX

view all

K243223 — Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)2026-09-22
K253480 — Capenergy C Equipments RF C200 and C400 Drakarian2026-07-10
K260647 — SPECCHIO2026-04-02
K253261 — Apollo Quattro (APQ-10M)2026-03-13
K252888 — NeoSculpt Plus2026-03-09

More clearances from Shenzhen Dongdixin Technology Co., Ltd.

view all

K260412 — TENS 7000 Rechargeable 4 Channel (TENS 7000H)2026-06-26
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

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