Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015526862

FEI Number

3015526862

Entity Name

SIMPLE MEDICAL (SHENZHEN) LIMITED

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

909 ChuangXiang Building 2, Minzhi Street, Longhua District, Shenzhen Guangdong 518131, CN

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Simple Medical (Shenzhen) Limited (Owner Number: 10088081)

Owner / Operator Contact Address

909 ChuangXiang Building 2, Minzhi Street, Longhua District, Shenzhen, CN-GD 518131, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LO Brace LSO Brace Hip Brace Knee Immobilizer Functional Knee Brace OA Knee Brace Post-Op Knee Brace Ankle Brace Walker Boot Air Ankle Wrist Brace Elbow Brace Thumb Brace Shoulder Brace Arm Sling

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2023-05-24
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2026-02-04
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	2024-06-17
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2023-05-24
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2023-05-24
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2023-05-24

Official Correspondent

Lorre Shi

US Agent Details

Erica Meyers Business: Simple Medical Products, Inc. Email: erica@simplemp.com Phone: (619) 9907332

Related Public Records

Same Entity

Simple Medical (Shenzhen) Limited

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 3015526862. Last updated year: 2026. Please use registration number 3015526862 when referencing this establishment in official correspondence.