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FDA 510(k)

TECAR Therapy Device (TC2000, TC2001)

K-Number: K252288 · 2026-10-13

ApplicantShenzhen Dongdixin Technology Co., Ltd.
Decision Date2026-10-13
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TECAR Therapy Device (TC2000, TC2001) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-10-13 under 510(k) number K252288. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECAR Therapy Device (TC2000, TC2001)?

TECAR Therapy Device (TC2000, TC2001) is a medical device that received FDA 510(k) clearance on 2026-10-13. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. The 510(k) number is K252288.

When did TECAR Therapy Device (TC2000, TC2001) receive FDA 510(k) clearance?

TECAR Therapy Device (TC2000, TC2001) received FDA 510(k) clearance on 2026-10-13, under 510(k) number K252288.

Who is the listed applicant for TECAR Therapy Device (TC2000, TC2001)?

The FDA 510(k) record lists Shenzhen Dongdixin Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TECAR Therapy Device (TC2000, TC2001)?

The FDA product code for TECAR Therapy Device (TC2000, TC2001) is PBX.

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Other records listing Shenzhen Dongdixin Technology Co., Ltd. as applicant

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Related Devices (Code: PBX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLCK253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.K260647SPECCHIOEl.En S.P.A.K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.K252888NeoSculpt PlusS&M Medical Co., Ltd.K250734OptiLUV DevicePollogen, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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