Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017610929

FEI Number

3017610929

Entity Name

HONG YU KANG TECHNOLOGY (GUANGDONG) CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Room 301,302,303, 3rd Floor, Building 12, Fuqiao Second District, Heping Community,Fuhai Street, Bao An,, Shenzhen Guangdong 518103, CN

Establishment Type(s)

Manufacture Medical Device,Repack or Relabel Medical Device,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Hong Yu Kang Technology (Guangdong) Co., Ltd. (Owner Number: 10078152)

Owner / Operator Contact Address

Room 301,302,303, 3rd Floor, Building 12, Fuqiao Second District, Heping Community,Fuhai Street, Bao An,, Shenzhen, CN-GD 518103, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Visual ear stick G1, G2, G3, G4, G5, G6, G7, G8, G9, G10 M11, M12, M13, M14, M15, M16, M17, M18, M19, M20 Cervical vertebra massager, eye massager, electric massage chair, electric massage table, massage stick, massage hammer fascia gun (massage health care products) massage pillow, massage cushion, massage belt, adult products, leg muscle massager Hearing Aid, Air-Conduction, Over the Counter:Behind-the-ear (BTE) Hearing Aid:GM-905T,GM-906T,GM-907T,GM-916T,GM-917T ITE Hearing Aid: GM-901T,GM-902T,GM-903T,GM-904T,GM-911T,GM-912T,GM-913T,GM-914T,GM-915T,GM-920T,GM-921T,GM-922T,GM-923T Hearing Aid, Air-Conduction, Over the Counter:Behind-the-ear (BTE) Hearing Aid,Models GM-351T,GM-352T,GM-353T,GM360T Hearing Aid, Air-Conduction, Over the Counter:Behind-the-ear (BTE) Hearing Aid,Models GM-371T,GM-372T,GM-373T,GM-380T Hearing Aid, Air-Conduction, Over the Counter:Behind-the-ear (BTE) Hearing Aid,Models:GM-312T,GM-313T,GM-314T,GM-320T Hearing Aid, Air-Conduction, Over the Counter:Behind-the-ear (BTE) Hearing Aid,Models GM-391T,GM-392T,GM-393T Hearing Aid, Air-Conduction, Over the Counter:Behind-the-ear (BTE) Hearing Aid,Models GM-321T,GM322T,GM-323T,GM-330T Hearing Aid, Air-Conduction, Over the Counter:Behind-the-ear (BTE) Hearing Aid,Models:GM-301T,GM-302T,GM-303T,GM-304T Hearing Aid, Air-Conduction, Over the Counter:Behind-the-ear (BTE) Hearing Aid,Models GM-341T,GM-342T,GM-343T,GM-350T, ITE Hearing Aid:GM-960T,GM-961T,GM-962T,GM-963T,GM-970T,GM-971T,GM972T,GM-973T,GM-980T,GM-981T,GM-982T,GM-983T,GM-990T Hearing Aid, Air-Conduction, Over the Counter:Behind-the-ear (BTE) Hearing Aid,Models GM-381T,GM382T,GM-383T,GM-390T ITE Hearing Aid:GM-991T,GM-992T,GM-993TGM-315T,GM-316T,GM-317T,GM-320T,GM-321T,GM-325T,GM-326T,GM-327T,GM-353T,GM-355T Hearing Aid, Air-Conduction, Over the Counter:Behind-the-ear (BTE) Hearing Aid,Models GM-361T,GM-362T,GM-363T,GM-370T Hearing Aid, Air-Conduction, Over the Counter:Behind-the-ear (BTE) Hearing Aid,Models:GM-306T,GM-307T,GM-310T,GM-311T Hearing Aid, Air-Conduction, Over the Counter:Behind-the-ear (BTE) Hearing Aid,Models GM-331T,GM-332T,GM-333T,GM-340T ITE Hearing Aid: GM-356T,GM-357T,GM-365T,GM-366T,GM-367T,GM-375T,GM-376T,GM-377T ITE Hearing Aid: GM-930T,GM-931T,GM-932T,GM-933T,GM-934T,GM-940T,GM-941T,GM-942T,GM-950T,GM-951T,GM-951T,GM-952T,GM-953T Hearing Aid, Air-Conduction, Over the Counter:Behind-the-ear (BTE) Hearing Aid:GM-936T,GM-937T,GM-955T,GM-956T,GM-957T Hearing Aid, Air-Conduction, Over the Counter:Behind-the-ear (BTE) Hearing Aid:GM-918T,GM-925T,GM-926T,GM-927T,GM-935T, Hearing Aid, Air-Conduction, Over the Counter:Behind-the-ear (BTE) Hearing Aid:GM-975T,GM-976T,GM-977T Nasal irrigation device K50, K51, K52, K53, K54, K55, K56, K57, K58, K59, K60 Behind-the-ear (BTE) Wireless Hearing Aids, Models: GM-303A,GM-313A,GM-323A,GM-333A,GM-343A,GM-353A,GM-363A,GM-373A Behind-the-ear (BTE) Wireless Hearing Aids, Models:GM-383A,GM-393A ITE Wireless Hearing Aid: GM--903A,GM-913A,GM-923A,GM-933A,GM-943A,GM-953A,GM-963A,GM-973A,GM-983A,GM-993A Tooth washers, electric toothbrushes K50, K51, K52, K53, K54, K55, K56, K57, K58, K59, K60 Behind-the-ear (BTE) aids, models: GM-11,GM-111,GM-100A,GM-105,GM-130 Behind-the-ear (BTE) aids, models: GM-200,GM-201,GM-220,GM-230,GM-250,GM-270,GM-290,GM-291,GM-297,GM-299 In-the-ear (ITE) aids, models: GM-908,GM-903,GM-907,GM-912,GM-913,GM-914,GM-915,GM-916,GM-917,GM-918,GM-919,GM-920 In-the-ear (ITE) aids, models: GM-910,GM-900F,GM-900,GM-900E,GM-900C,GM-900G,GM-900B,GM-902,GM-904,GM-901A Bluetooth hearing aids, models: GM-301,GM-302,GM-303,GM-304,GM-305,GM-307 Visual dental mirror, Y1, Y2, Y3, Y4, Y5, Y6, Y7, Y8, Y9, Y10

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JYT	Pick, Microsurgical Ear	Ear, Nose, Throat	Class 1	874.4420	2021-03-30
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2021-03-30
QUF	Hearing Aid, Air-Conduction, Over The Counter	Ear, Nose, Throat	Class 1	874.3300	2022-11-16
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	Class 1	874.5550	2021-03-30
OSM	Hearing Aid, Air-Conduction With Wireless Technology, Prescription	Ear, Nose, Throat	Class 2	874.3305	2022-11-16
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2021-03-30
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2020-10-12
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2021-03-30

Official Correspondent

Hongbo Zhang

US Agent Details

Christine Wang Email: Christinewang614@gmail.com Phone: (918) 9988916

Related Public Records

Same Entity

Hong Yu Kang Technology (Guangdong) 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
K892457	Telstar Electronics, Inc.	TELSTAR MODEL 1/3 ITE HEARING AID	1989-06-06
K760996	Unitron Industries, Inc.	HEARING AID (MODEL 695D, 905 & 960P)	1976-11-16
K840825	Maico Hearing Instruments, Inc.	SERIES MR IN-THE-EAR CUSTOM HEARING AID	1984-03-30
K946253	Maico Hearing Instruments, Inc.	MAICO IN-THE-EAR MODEL RD 201	1995-01-30
K863975	Gn Danavox, Inc.	CUSTOM IN-THE-EAR	1986-11-07

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017610929. Last updated year: 2026. Please use registration number 3017610929 when referencing this establishment in official correspondence.