Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017429279

FEI Number

3017429279

Entity Name

Guangdong Okay Technology Co.,Ltd.

City/State/Country

Zhong Shan Guangdong, CN

Establishment Address

Area A,B,F 1/F, Area A 2/F, 3/F, No.1374, Jinjing Road, PingNan Village, SanXiang Town, Zhong Shan Guangdong 528463, CN

Establishment Type(s)

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

Owner / Operator

Guangdong Okay Technology Co.,Ltd. (Owner Number: 10072147)

Owner / Operator Contact Address

Area A,B,F 1/F, Area A 2/F, 3/F, No.1374, Jinjing Road, PingNan Village, SanXiang Town, Zhong Shan, CN-GD 528463, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Griffin Water Powered Ear Cleaner RF Anion Hair Nourishing Comb Nasal atomizer washer: OG-5661 Facial Steamer Calming heat massaging Flexi Wrap Calming Heat Back Wrap Calming heat Deluxe massaging Flexi Wrap Calming heat massaging Neck wrap CALMING HEAT MASSAGING NECK WRAP CALMING HEAT MASSAGING SHOULDER WRAP Calming heat massaging CALMING HEAT DELUXE MASSAGING NECK WRAP CALMING HEAT DELUXE MASSAGING SHOULDER WRAP Wush Powered Ear Cleaner Calming Heat shoulder Wrap Cold Pack Calming Heat Knee Wrap Cold Pack Dental Calculus Remover ; Brand:BeastRose ; Model:YR199 Dental Calculus Remover

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OGQ	Ear Irrigation Kit	General Hospital	Class 1	880.6960	2021-12-19
LJL	Detectors And Removers, Lice, (Including Combs)	General Hospital	Class 1	880.5960	2020-05-03
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	Class 1	874.5550	2024-03-18
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Anesthesiology	Class 1	868.5460	2020-04-26
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2021-10-22
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2023-12-14
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2023-05-10
ELA	Instrument, Hand, Calculus Removal	Dental	Class 1	872.4565	2022-03-06

Official Correspondent

Haiyan Long

US Agent Details

Yueting Zhu Business: SOUTH BAY INNOVATION LLC Email: southbayinnovation@southbayinnovation.com Phone: (424) 3769142

Related Public Records

Same Entity

Guangdong Okay 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
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13

Similar Registrations

Registration Number	Establishment Name	Location
3012107263	DOCTOR EASY MEDICAL PRODUCTS CORPORATION	Orange Park, FL, US
3021656665	SHENZHEN OBESTEC INDUSTRIAL CO.,LTD	Shenzhen Guangdong, CN
2183416	APOTHECARY PRODUCTS, LLC.	BURNSVILLE, MN, US
3016458459	Shenzhen Heearly Technology Co.,Ltd.	Bao an District, Shenzhen Guangdong, CN
3013559620	EOSERA INC	Fort Worth, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017429279. Last updated year: 2026. Please use registration number 3017429279 when referencing this establishment in official correspondence.