Cleared Traditional

K252288 - TECAR Therapy Device (TC2000, TC2001)

K252288 is an FDA 510(k) clearance for TECAR Therapy Device (TC2000, manufactured by Shenzhen Dongdixin Technology Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code PBX cleared through the Traditional 510(k) pathway after a 447-day FDA review.

K252288 · Shenzhen Dongdixin Technology Co., Ltd. · General & Plastic Surgery device
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Oct 2026
Decision
447d
Days
Class 2
Risk

K252288 is an FDA 510(k) clearance for the TECAR Therapy Device (TC2000, TC2001). Classified as Massager, Vacuum, Radio Frequency Induced Heat (product code PBX), Class II - Special Controls.

Submitted by Shenzhen Dongdixin Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 13, 2026 after a review of 447 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

FDA 510(k) Submission Details - K252288

510(k) Number K252288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2025
Decision Date October 13, 2026
Days to Decision 447 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
332d slower than avg
Panel avg: 115d · This submission: 447d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PBX Device Classification - Class 2, Special Controls

Product Code PBX Massager, Vacuum, Radio Frequency Induced Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Generates Heat In Body Tissues For Minor Relief Of Minor Aches And Pain. Mechanical Massaging To Provide A Temporary Reduction In The Appearance Of Cellulite.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - PBX Massager, Vacuum, Radio Frequency Induced Heat

All 80
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K252288 · TECAR Therapy Device (TC2000, TC2001)
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