Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008997160

FEI Number

3008997160

Entity Name

BUY ASIA ENTERPRISE LTD

City/State/Country

Dongguan City Guangdong, CN

Establishment Address

No 703, TOWER1, XINHUI PLAZA, CHANGPING TOWN,, Dongguan City Guangdong 523560, CN

Establishment Type(s)

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

Owner / Operator

Buy Asia Enterprise Ltd (Owner Number: 10038240)

Owner / Operator Contact Address

NO. 703, TOWER 1, XINHUI PLAZA, CHANGPING TOWN,, Dongguan City, CN-GD 523560, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Massage Shower Strap Telescoping Wheelchair Ramp MASSAGER, THERAPEUTIC, MANUAL FULL SIZE ACUPRESSURE MAT Reflexology wand Cane Tip ICE CANE TIP Quad Cane Tip SUPER BIG FOOT CANE TIP Silicone Ear Plugs WALKING STICK WITH SEAT toe and bunion protector silicone breast Tooth Stain Eraser LED READING GLASSES Mini Bike with Exercise Computer Pedal Cycle Exercise Bike Eye Drop Guide Knee Support KNEE PROTECTOR Finger Sleeves Metatarsal Cushion W/ Toe Loop Protective Toe Caps FOAM BUNION SHIELD Gel Arch Sleeve Gel Comfort Tailor Gel Bunion Shield Silicone Shock Absorbers Metatarsal Cushion 1 Pr. BUNION RELIEF TUBE -1PR Toe Separators S/8 Gel Foot Cushions Gel Pads S/12 Medical Bracelet Gel Toe Straighteners Toe Straightener walker wheel 5" HIMALAYAN SALT DETOX BLOCKS FOR FEET S/2 Medical Shoe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2020-02-20
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	2017-06-30
LYG	Massager, Therapeutic, Manual	Physical Medicine	Class 1	890.5660	2011-09-27
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2014-05-07
EWD	Protector, Hearing (Insert)	Unknown	Class U	N/A	2024-07-29
IPS	Cane	Physical Medicine	Class 1	890.3075	2018-08-06
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2015-01-06
NOJ	Prosthesis, Breast, External, No Adhesive	General, Plastic Surgery	Class 1	878.3800	2017-07-10
MAU	Eraser, Dental Stain	Dental	Class 1	872.6855	2024-02-05
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2012-03-06
IOD	Components, Exercise	Physical Medicine	Class 1	890.5350	2013-06-12
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2014-04-11
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2018-11-11
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2011-11-07
NXQ	Reminder, Medication	Physical Medicine	Class 1	890.5050	2013-05-22
IQM	Splint, Temporary Training	Physical Medicine	Class 1	890.3025	2015-12-31
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2013-12-25
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2017-12-10
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2023-04-25

Official Correspondent

Jeremy Chang

US Agent Details

Ho Shan Wang Email: acmebiotechs@gmail.com Phone: (623) 9864377

Related Public Records

Same Entity

Buy Asia Enterprise 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
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09

Similar Registrations

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3032027168	GUANGDONG ZHONGZE ALUMINUM CO., LTD	Foshan Guangdong, CN
3019502344	FOSHAN MAIKANG MEDICAL EQUIPMENT CO., LTD	Foshan Guangdong, CN
3004126239	MERCHSOURCE LLC	Irvine, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008997160. Last updated year: 2026. Please use registration number 3008997160 when referencing this establishment in official correspondence.