Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043728465

FEI Number

3043728465

Entity Name

GUANGZHOU SOWEN DIGITAL TECHNOLOGY CO., LTD.

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

Room 487 (office only) No. 85 Gaopu Road Guangzhou Guangdong Province 510000 CN, Guangzhou Guangdong 510000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Guangzhou Sowen Digital Technology Co., Ltd. (Owner Number: 10095140)

Owner / Operator Contact Address

Room 487 (office only) No. 85 Gaopu Road Guangzhou Guangdong Province 510000 CN, Guangzhou, CN-GD 510000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Rehabilitation Robot Gloves & Portable Hand Trainer; Model: ML-113,ML-115,ML-116,ML-118, D00900, P01138; Brand: JBMBHC Rehabilitation Robot Gloves & Portable Hand Trainer; Model: 5179,937,952,933,960,965,SW225; Brand: JBMBHC Rehabilitation Robot Gloves & Portable Hand Trainer; Model: SW226, SW227, SW228, SW229, SW330; Brand: JBMBHC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QKC	Interactive Rehabilitation Exercise Device, Prescription Use	Physical Medicine	Class 2	890.5360	2026-01-28

Official Correspondent

Huazai Liang

US Agent Details

Wang Jack Business: CID TESTING CERTIFICATION CONSULTING LTD. Email: jack-fda@outlook.com Phone: (303) 5861208

Related Public Records

Same Entity

Guangzhou Sowen Digital Technology Co., Ltd.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043728465. Last updated year: 2026. Please use registration number 3043728465 when referencing this establishment in official correspondence.