Xiamen Ortocare Sports Health Co., Ltd.
Registered establishment in Xiamen Free Trade Zone, Fujian, China. 32 device types.
Xiamen Ortocare Sports Health Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Cane, Sling, Arm and 30 other device types. Its earliest product listing with the FDA dates from 2017.
Registration
| Registered name | XIAMEN ORTOCARE SPORTS HEALTH CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3012841710 |
| FEI number | 3012841710 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Xiamen Free Trade Zone |
|---|---|
| Province | Fujian |
| Address | Office 218, New Times Building, NO.1 Huli Avenue, Huli District |
| Postal code | 361006 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Adaptor, Hygiene | Class 1 | shower chair | 2024 | 193 |
| Bed, Ac-Powered Adjustable Hospital | Class 2 | Medical bed | 2021 | 95 |
| Board, Scooter, Prone | Class 1 | knee scooter | 2018 | 8 |
| Cane | Class 1 | Crutch,walking stick | 2020 | 97 |
| Chair, Adjustable, Mechanical | Class 1 | Toilet chair | 2020 | 46 |
| Chair, With Casters | Class 1 | patient transfer equipment | 2020 | 85 |
| Cover, Cast | Class 1 | waterproof cast dressing cover | 2024 | 31 |
| Cover, Limb | Class 1 | Prosthetic Joint | 2024 | 24 |
| Exerciser, Powered | Class 1 | Physical therapy device | 2021 | 27 |
| Gown, Examination | Class 1 | Disposable gown | 2020 | 109 |
| Joint, Ankle, External Brace | Class 1 | Walker Braces, Ankle Braces | 2017 | 134 |
| Joint, Hip, External Brace | Class 1 | HIP Braces | 2017 | 33 |
| Joint, Knee, External Brace | Class 1 | Knee Braces, Goat | 2017 | 137 |
| Mask, Scavenging | Class 1 | face mask | 2020 | 158 |
| Massager, Therapeutic, Electric | Class 1 | Air pressure massager, leg massager, knee massager, back massager,neck massager | 2018 | 437 |
| Mattress, Air Flotation, Alternating Pressure | Class 2 | Medical mattress | 2021 | 52 |
| Non-Surgical Gown | Class 1 | Isolation Suit | 2020 | 318 |
| Orthosis, Cervical | Class 1 | Cervical Collars | 2017 | 114 |
| Orthosis, Corrective Shoe | Class 1 | Post OP Shoes | 2017 | 51 |
| Orthosis, Limb Brace | Class 1 | ORTHOPEDIC BRACES, Posture correction device | 2017 | 144 |
| Orthosis, Lumbar | Class 1 | Back Brack Braces | 2017 | 110 |
| Pack, Hot Or Cold, Disposable | Class 1 | hot/cold therapy products | 2018 | 176 |
| Pack, Hot Or Cold, Water Circulating | Class 2 | HOT/Cold,water Circulating,cold Therapy Device | 2019 | 45 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | Medical Disposable goggle | 2020 | 384 |
| Shield, Protective, Personnel | Class 1 | Protective Eye Shield | 2020 | 78 |
| Sling, Arm | Class 1 | ARM Slings | 2017 | 126 |
| Sling, Arm, Overhead Supported | Class 1 | SHOULDER SLINGS, Kangaroo Shoulder Sling KSS001,Kahuna Brace KB001,Mini Kahuna Brace MKB001 | 2017 | 31 |
| Splint, Clavicle | Class 1 | Clavical Brace | 2024 | 31 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | Class 1 | Night Splints | 2017 | 62 |
| Splint, Hand, And Components | Class 1 | Wrist Braces, Finger Splints | 2017 | 144 |
| Support, Arm | Class 1 | Elbow Braces | 2017 | 72 |
| Wound Dressing Kit | Class 2 | wound care kit | 2024 | 12 |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Walker braces, Knee braces, Orthopedic supports, Back braces, Shoulder braces |
|---|---|
| Certifications | ISO13485, FDA, CE MDR, SFDA |
| OEM and ODM | Offered |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.