Shijiazhuang Aofeite Medical Device Co., Ltd.
Registered establishment in Shijiazhuang, Hebei, China. 28 device types.
Shijiazhuang Aofeite Medical Device Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Crutch, Bag, Ice and 26 other device types. Its earliest product listing with the FDA dates from 2010.
Registration
| Registered name | Shijiazhuang Aofeite Medical Device Co.,Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3009068676 |
| FEI number | 3009068676 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 石家庄奥非特医疗器械有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Shijiazhuang |
|---|---|
| Province | Hebei |
| Address | 2nd Floor, Building 3D, Liandong U-Valley Industrial Park, No.695 Tianshan South Street, High-tech Zone, |
| Postal code | 050000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Apparatus, Traction, Non-Powered | Class 1 | Neck Stretcher | 2016 | 44 |
| Bag, Ice | Class 1 | Ice bag, Gel Pack (hot/cold mutipul use pack) | 2014 | 86 |
| Band Or Belt, Pelvic Support | Class 1 | postpartum belly belt, Maternity belly support belt | 2010 | 54 |
| Bottle, Hot/Cold Water | Class 1 | Bottle, HOT/Cold Water | 2023 | 37 |
| Cane, Safety Walk | Class 1 | 2018 | 25 | |
| Cover, Limb | Class 1 | Arthritis Gloves | 2013 | 24 |
| Crutch | Class 1 | crutch, quad cane, seat cane, walking stick, blind cane | 2010 | 112 |
| Device, Acupressure | Class U | Device, Acupressure, Knee brace, knee wrap, knee pad | 2010 | 4 |
| Dilator, Nasal | Class 1 | Stop Snoring Solution, Anti Snore Belt, Stop Snoring Chin Strap, Chin Strap Belt, Anti Snore Jaw Supporter | 2016 | 55 |
| Exerciser, Non-Measuring | Class 1 | Breathing Muscle Trainer | 2024 | 82 |
| Insoles, Medical | Class 1 | Silicone Heel UP | 2018 | 34 |
| Joint, Ankle, External Brace | Class 1 | walker brace, ankle wrap, socks | 2010 | 134 |
| Joint, Knee, External Brace | Class 1 | Joint, Knee, External Brace | 2020 | 137 |
| Mask, Scavenging | Class 1 | 2020 | 158 | |
| Massager, Therapeutic, Electric | Class 1 | tens unit, Physiotherapy heating massager | 2013 | 437 |
| Massager, Therapeutic, Manual | Class 1 | Massage Slippers, socks | 2013 | 113 |
| Mattress, Flotation Therapy, Non-Powered | Class 1 | Air mattress, air cushion | 2010 | 30 |
| Non-Surgical Gown | Class 1 | armor | 2021 | 318 |
| Orthosis, Cervical | Class 1 | Air neck traction, over-door neck traction device, shoulder wrap, neck wrap, cervial collar, Neck Magic Air Cushion | 2010 | 114 |
| Orthosis, Limb Brace | Class 1 | Orthosis, Limb Brace | 2026 | 144 |
| Orthosis, Lumbar | Class 1 | Y046, wrist wrap, Back/lumbar/waist support brace belt | 2010 | 110 |
| Orthosis, Truncal/Orthosis, Limb | Class 1 | posture corrector, elbow wrap | 2010 | 68 |
| Pack, Hot Or Cold, Reusable | Class 1 | Gel Pack(hot/cold mutipul use pack), Pack, hot or cold, reusable | 2024 | 178 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | 2018 | 384 | |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | Class 1 | wire splint | 2010 | 62 |
| Splint, Hand, And Components | Class 1 | Splint, Hand, Andcomponents | 2026 | 144 |
| Support, Arm | Class 1 | Support, ARM | 2026 | 72 |
| Surgical Table Cushion | Class 1 | Covered Body | 2013 | 4 |
Clearances
No clearance names Shijiazhuang Aofeite Medical Device Co., Ltd. as applicant. One is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K211823 | 2021-09-01 | MVV | Traditional | Wellspring Pharmaceutical Corporation |
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.
The manufacturer named here can complete this record.