Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012841710

FEI Number

3012841710

Entity Name

XIAMEN ORTOCARE SPORTS HEALTH CO.,LTD.

City/State/Country

Xiamen Free Trade Zone Fujian, CN

Establishment Address

Office 218, New Times Building, NO.1 Huli Avenue, Huli District, Xiamen Free Trade Zone Fujian 361006, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

XIAMEN ORTOCARE SPORTS HEALTH CO.,LTD. (Owner Number: 10056512)

Owner / Operator Contact Address

Office 218, New Times Building, NO.1 Huli Avenue, Huli District, Xiamen Free Trade Zone, CN-FJ 361006, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Prosthetic Joint Disposable gown Physical therapy device Medical Disposable goggle CERVICAL COLLARS ELBOW BRACES FINGER SPLINTS WRIST BRACES POST OP SHOES shower chair Crutch,walking stick KNEE BRACES, GOAT Air pressure massager, leg massager, knee massager, back massager,neck massager ORTHOPEDIC BRACES, Posture correction device Protective Eye Shield Medical mattress wound care kit Clavical Brace NIGHT SPLINTS Medical bed Toilet chair WALKER BRACES ANKLE BRACES waterproof cast dressing cover HOT/COLD,WATER CIRCULATING,COLD THERAPY DEVICE knee scooter BACK BRACK BRACES patient transfer equipment

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IPM	Cover, Limb	Physical Medicine	Class 1	890.3025	2024-12-12
FME	Gown, Examination	General Hospital	Class 1	880.6265	2020-03-26
BXB	Exerciser, Powered	Physical Medicine	Class 1	890.5380	2021-12-18
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-03-26
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2017-12-21
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2017-12-21
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2017-12-21
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2017-12-21
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2024-07-25
IPS	Cane	Physical Medicine	Class 1	890.3075	2020-12-15
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2017-12-21
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2018-12-17
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2017-12-18
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2020-03-26
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	2021-12-18
MCY	Wound Dressing Kit	General Hospital	Class 2	880.5075	2024-07-25
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2024-12-12
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2017-12-21
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2021-12-18
INN	Chair, Adjustable, Mechanical	Physical Medicine	Class 1	890.3100	2020-12-15
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2017-12-21
KIA	Cover, Cast	General Hospital	Class 1	880.6185	2024-07-25
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2019-12-15
KNL	Board, Scooter, Prone	Physical Medicine	Class 1	890.5370	2018-12-17
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2017-12-21
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2020-12-15

Official Correspondent

Xinjie Shao

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

XIAMEN ORTOCARE SPORTS HEALTH 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
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09
K935837	Healthcare Designs	AIRHYTHM HEALTHCARE BED	1994-06-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
Z-0016-2007	Sunrise Medical CCG, Inc.	2	Joerns Ultra Care 770 Model AC Powered Beds with model numbers U770, U770 AL , U770 GNDAL. Sunrise Medical, Long Term Care Division, 5001 Joerns Drive, Stevens Point, WI 54481 USA.
Z-0017-2007	Hill-Rom, Inc.	2	Hill-Rom VersaCare Hospital Bed with optional patient pendant P3207A01 or P3207A02; model P3200.
Z-0019-2015	Arjo Hospital Equipment AB Verkstadsvagen	2	ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.
Z-0026-2007	Extended Care Air Therapy Systems Inc	2	ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012841710. Last updated year: 2026. Please use registration number 3012841710 when referencing this establishment in official correspondence.