FDA Registration
Active
🇨🇳 China
HENGSHUI XUKANG MEDICAL APPLIANCES CO., LTD.
Reg #: 3013527364
·
FEI: 3013527364
·
Expires 2026
Products
21
Proprietary Names
25
Establishment Types
3
Classifications
21
Registration Details
- Registration Name
- HENGSHUI XUKANG MEDICAL APPLIANCES CO., LTD.
- Registration Number
- 3013527364
- FEI Number
- 3013527364
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Xinzheng Village, Anping County
- City
- Hengshui City Hebei
- Country
- CN
Owner / Operator
- Firm Name
- Hengshui Xukang Medical Appliances Co., Ltd.
- Operator Number
- 10053418
- Address
- Xinzheng Village, Anping County, Hebei Province
- City
- Hengshui City
- State
- Hebei
- Postal Code
- 053605
- Country
- CN
- Correspondent
- Jiacheng Li
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.,
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Truncal/Orthosis, Limb | MRI | Class 1 | Physical Medicine | No | 2016-12-03 |
| Mattress, Air Flotation, Alternating Pressure | FNM | Class 2 | General Hospital | No | 2016-12-03 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2016-12-03 |
| Splint, Extremity, Inflatable, External | FZF | Class 1 | General, Plastic Surgery | No | 2021-12-30 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2016-12-03 |
| Cane | IPS | Class 1 | Physical Medicine | No | 2016-12-03 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2019-10-25 |
| Crutch | IPR | Class 1 | Physical Medicine | No | 2016-12-03 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2016-12-03 |
| Stretcher, Patient Restraint | NZD | Class 1 | General Hospital | No | 2021-12-30 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2016-12-03 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2017-11-08 |
| Orthosis, Corrective Shoe | KNP | Class 1 | Physical Medicine | No | 2016-12-03 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2016-12-03 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2016-12-03 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2016-12-03 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | Class 1 | General, Plastic Surgery | No | 2016-12-03 |
| Binder, Abdominal | FSD | Class 1 | General Hospital | No | 2018-12-08 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2018-12-08 |
| Splint, Temporary Training | IQM | Class 1 | Physical Medicine | No | 2017-11-08 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2022-03-15 |
Proprietary Names
Posture Corrector, Neck brace, Back Support, Body Pillow, Rib fixation band
Bedsore Pad
Orthosis, Limb Fixed Belt, Knee Elbow Orthosis, Medical Fixed Belt, Pregnant Support Belt
Plantar Fasciitis Night Splint
Tourniquet
Canes
Bunion corrector, Foot Arch Support, Ankle Brace-ASTN
Crutches
Bandages
Leg Calf Stretcher
Kneepad, Ankle Support, Elbow Support, Shoulder Support, Wrist Support
Knee support, Knee Brace-ASTN, Arthritis Gloves
Arm sling; Arm Sling with Pillow
Bunion corrector,Foot Arch Support
Walker Boot
Elastic Stretch Net Cap
Walking Aid
Neck Support
Cervical Collar, Sponge Cervical Collar, Philadelphia Cervical Collar,Inflating Neck Support, Lift Neck Support
Finger Splint,Rolling Splint
Ostomy Abdominal Belt
Waist Support
Hip Joint brace
Hallus Valgus
Finger BraceASTN, Finger Support
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)