Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008345424

FEI Number

3008345424

Entity Name

Guangdong Ace-Tec Co., Ltd.

City/State/Country

Dongguan Guangdong, CN

Establishment Address

No.420, Jinxing Road, Xixi Industrial Park, Liaobu Town, Dongguan Guangdong 523400, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Guangdong Ace-Tec Co., Ltd. (Owner Number: 10045403)

Owner / Operator Contact Address

No.420, Jinxing Road, Xixi Industrial Park, Liaobu Town, Dongguan, CN-GD 523400, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SR12D Body Roller FCB12 face brush FBB9 Rolling Massager FCB5 Face brush FCD4 face brush LED Therapy Mask (SR11CM,SR11CM1,SR11CM2,SR11CM3,SR11CM4,SR11CM5,SR11CM6,SR11CM7,SR11CM8) ZIIP HALO PowerDot PD-01M2 Muscle Stimulator TCB1 electric toothbrush TCC7, Electric toothbrush

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2013-11-12
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2025-12-11
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2025-12-11
NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes	Neurology	Class 2	882.5890	2025-04-10
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2022-06-02
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2023-06-12
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2023-06-12
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2020-10-27

Official Correspondent

Lucy Yang

US Agent Details

Anny Zhao Business: Hlongmed International Ltd. Email: usagent@hlongmed.com Phone: (503) 3344880

Related Public Records

Same Entity

Guangdong Ace-Tec Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221200	Xbody Hungary Kft.	XBody Go USA, XBody Pro USA	2023-01-31

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008345424. Last updated year: 2026. Please use registration number 3008345424 when referencing this establishment in official correspondence.