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The Tracker / October 2026 / K252288

510(k) cleared

TECAR Therapy Device (TC2000, TC2001)

Shenzhen Dongdixin Technology Co., Ltd. · Oct 13, 2026 · K252288

FDA cleared the TECAR Therapy Device (TC2000, TC2001) from Shenzhen Dongdixin Technology Co., Ltd. on Oct 13, 2026 under K252288, a traditional 510(k). The device falls under product code PBX, Massager, Vacuum, Radio Frequency Induced Heat, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jul 23, 2025. The decision came 447 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Shenzhen Dongdixin Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K260412 (TENS 7000 Rechargeable 4 Channel (TENS 7000H)).

Questions & Answers

What did FDA clear under K252288?

K252288 is the FDA 510(k) for TECAR Therapy Device (TC2000, TC2001), submitted by Shenzhen Dongdixin Technology Co., Ltd.. FDA's decision date was Oct 13, 2026, under product code PBX (Massager, Vacuum, Radio Frequency Induced Heat).

Who makes the TECAR Therapy Device (TC2000, TC2001)?

Shenzhen Dongdixin Technology Co., Ltd., based in Shenzhen, is the applicant of record for K252288.

How long did the K252288 review take?

FDA received the submission on Jul 23, 2025 and issued its decision on Oct 13, 2026, 447 days later.

← All decisions in October 2026

Sources