Xiamen Huakang Orthopedic Co., Ltd.
Registered establishment in Xiamen, Fujian, China. 17 device types.
Xiamen Huakang Orthopedic Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Crutch, Sling, Arm and 15 other device types. Its earliest product listing with the FDA dates from 2017.
Registration
| Registered name | XIAMEN HUAKANG ORTHOPEDIC CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008903689 |
| FEI number | 3008903689 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 厦门华康奥斯医疗器械有限公司 |
|---|---|
| Source | customs registration record |
Location
| City | Xiamen |
|---|---|
| Province | Fujian |
| Address | 2F,Building #13, No. 2881 Dongfu Avenue, Haicang District |
| Postal code | 361027 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Face Mask | 2020 | 439 |
| Band Or Belt, Pelvic Support | Class 1 | Lumbo-Sacral back brace | 2017 | 54 |
| Binder, Abdominal | Class 1 | Abdominal Binder | 2017 | 20 |
| Crutch | Class 1 | crutches | 2018 | 112 |
| Joint, Ankle, External Brace | Class 1 | Ankle, external brace | 2017 | 134 |
| Joint, Knee, External Brace | Class 1 | knee brace, Hand Splint | 2017 | 137 |
| Non-Surgical Gown | Class 1 | Isolation Gown | 2020 | 318 |
| Orthosis, Cervical | Class 1 | Cervical collar | 2017 | 114 |
| Orthosis, Limb Brace | Class 1 | elbow brace, hand braces, hip brace, foot brace | 2018 | 144 |
| Orthosis, Lumbar | Class 1 | Orthosis Lumbar | 2026 | 110 |
| Orthosis, Truncal/Orthosis, Limb | Class 1 | Scoliosis Brace | 2025 | 68 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | Goggles | 2020 | 384 |
| Sling, Arm | Class 1 | Shoulder/Arm Sling | 2017 | 126 |
| Splint, Clavicle | Class 1 | Clavicle Splint | 2017 | 31 |
| Stocking, Elastic | Class 1 | Limb brace | 2017 | 32 |
| Support, Hernia | Class 1 | Hernia truss support | 2022 | 14 |
| Support, Patient Position | Class 1 | Positioning Straps | 2022 | 66 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2014 |
|---|---|
| Employees | 300 |
| Factory area | 10000 |
| Main products | Ankle brace, Walker boot, Knee brace, Back support, Cervical collar |
| Certifications | FDA, CE, MDR, ISO13485 |
| Export markets | Europe, North America, Southeast Asia, Middle East, South America, Africa |
| OEM and ODM | Offered |
Nearby Manufacturers
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.
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