510(k) clearance

TECAR Therapy Device (TC2000, TC2001)

FDA 510(k) source

510(k) number

K252288

Applicant

Shenzhen Dongdixin Technology Co., Ltd.

Decision date

Oct 13, 2026

Date received

Jul 23, 2025

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

PBX

Device type

Massager, Vacuum, Radio Frequency Induced Heat

Device class

Class II

Regulation

21 CFR 878.4400

Advisory committee

General, Plastic Surgery

Statement or summary

Statement

Third party

N

Location

Shenzhen, CN