Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011905669

FEI Number

3011905669

Entity Name

SHENZHEN KONMED TECHNOLOGY CO., LTD

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

601, Building B4, Shenchengtou creative factory life science park, Julongshan A Road, Xiuxin block, Kengzi Street, Pingshan District, Shenzhen Guangdong 518118, CN

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Shenzhen Konmed Technology Co., Ltd (Owner Number: 10054707)

Owner / Operator Contact Address

601, Building B4, Shenchengtou creative factory life science park, Julongshan A Road, Xiuxin block, Kengzi Street, Pingshan District, Shenzhen, CN-GD 518118, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K220161

PMA Number

N/A

All Registered Proprietary Names

Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013) Incontinence Stimulation Electrode (Rectal Probe: KM-502, KM-5018) Mouth to mouth shield Mouthpiece CPR Mask KM-110 KM-101 KM-102 Pelvic Muscle Trainer STIMULATOR Electrode Lead Wires Biofeedback Nerve and Muscle Stimulator (Models: KM530B, KM531B, KM536, KM537)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2018-01-23
HIR	Perineometer	Obstetrics/Gynecology	Class 2	884.1425	2024-02-29
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Gastroenterology, Urology	Class 2	876.5320	2024-02-29
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2017-06-02
KXQ	Vibrator For Therapeutic Use, Genital	Obstetrics/Gynecology	Class 2	884.5960	2024-12-30
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2020-12-08
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Gastroenterology, Urology	Class 2	876.5320	2020-12-08
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2020-12-08
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2026-03-23
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2022-08-22
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Gastroenterology, Urology	Class 2	876.5320	2022-08-22

Official Correspondent

Shui Shan Yin

US Agent Details

DENNIS XU DENNIS XU Business: Performance International, Corp. Email: ybx99@yahoo.com Phone: (919) 8590478

Related Public Records

Same Entity

Shenzhen Konmed Technology 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
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03
K091762	Covidien	DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE	2009-12-22

Similar Registrations

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3004695199	INCEREB LTD	Dublin Dun Laoghaire-Rathdown, IE
3005581220	SPES MEDICA S.P.A	BATTIPAGLIA Salerno, IT
9616086	DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.	TIJUANA Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011905669. Last updated year: 2026. Please use registration number 3011905669 when referencing this establishment in official correspondence.