FDA Registration
Active
🇨🇳 China
Xiamen Weiyou Intelligent Technology Co.,Ltd
Reg #: 3011539161
·
FEI: 3011539161
·
Expires 2026
Products
9
Proprietary Names
57
Establishment Types
4
Classifications
9
Registration Details
- Registration Name
- Xiamen Weiyou Intelligent Technology Co.,Ltd
- Registration Number
- 3011539161
- FEI Number
- 3011539161
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Unit 3 No. 6 Xianghong Road,Torch Hi-Tech Zone Industrial Park,Xiang'an District
- City
- xiamen Fujian
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K243791
Owner / Operator
- Firm Name
- Xiamen Weiyou Intelligent Technology Co.,Ltd
- Operator Number
- 10059059
- Address
- Unit 3 No. 6 Xianghong Road,Torch Hi-Tech Zone Industrial Park,Xiang'an District
- City
- Xiamen
- State
- Fujian
- Postal Code
- 361101
- Country
- CN
- Correspondent
- Kelly Guo
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 |
|---|---|---|---|---|---|
| Bed, Manual | FNJ | Class 1 | General Hospital | No | 2025-02-05 |
| Mattress, Air Flotation, Alternating Pressure | FNM | Class 2 | General Hospital | No | 2019-04-04 |
| Massager, Powered Inflatable Tube | IRP | Class 2 | Physical Medicine | No | 2025-02-13 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2026-05-25 |
| Pack, Hot Or Cold, Water Circulating | ILO | Class 2 | Physical Medicine | No | 2023-05-18 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2019-04-04 |
| Bed, Ac-Powered Adjustable Hospital | FNL | Class 2 | General Hospital | No | 2022-03-31 |
| Exerciser, Powered | BXB | Class 1 | Physical Medicine | No | 2022-08-01 |
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2022-04-01 |
Proprietary Names
Manuel Hospital Bed: CM-MHB-02, CM-MNB-02
Air Mattress with Pump (Model: VU-602/6007)
Air Mattress with Pump (Model: VU-AMP01)
Air Mattress with Pump (Model: VU-AMP02)
Air Pressure Therapy System (VU-IPC06, VU-IPC04, VU-NIPC02)
Air Pressure Therapy System:VU-IPC12B
Air Pressure Therapy System:VU-IPC05D
Air Pressure Therapy System:VU-IPCA8
Air Pressure Therapy System:VU-IPCRB8
Air Pressure Therapy System:VU-IPCS8
Air Pressure Therapy System:VU-IPC05B
Air Pressure Therapy System:VU-IPCU8
Air Pressure Therapy System:VU-IPC06B
Air Pressure Therapy System:VU-IPCM4
Air Pressure Therapy System:VU-IPC04B
Air Pressure Therapy System:VU-IPCV5
Red Light Therapy Mat; Red Light Therapy Hands; Red Lgiht Therapy For Knee; Red Light Therapy Lamp; Heating Waist Belt;
Heating Vibration Massage Wrist; Neck Heating Massage; Foot Heating Massage; LED Therapy Light' RED Light Therapy;
Heating Vibration Massage Elbow; Heating Vibration Massage knee Pad; Heating Vibration Massage Shoulder;
Red Light Therapy System
Red Light Hair Cap; Red Light Therapy Belt; Red Light Therapy Sleeping Bag; Red Light Therapy For Body;
Heating Sleeping Bag; Heating Ankles; Heating Neck; Heating Knee Pad; Foot Heating; Heating Shoulder
Air Pressure Therapy System (Model: VU-IPC4M)
Hot Cold Water Circulating System (Model: COT01, COTO2, COT03)
Hot Cold Water Circulating System (Model: VU-COT01, VU-COT02, VU- COT03),
Hot Cold Water Circulating System (Model: VU-COT01)
Hot Cold Water Circulating System (Model: VU-COT04-V1, VU-COT04-V2, CX3)
Hot Cold Water Circulating System (Model: VU-COT01-V1, VU-COT01-V2, VU-COT03-V1, VU-COT03-V2)
Hot Cold Water Circulating System (Model: VU-COT01, GX7, CX9, VU-COTO2, VU-COT03, GX3, GX5, CX5, CX7)
AC Compression Machine:VU-IPC01,VU-IPC02,VU-NIPC01,VU-NIPC02,VU-IPC03,VU-IPC04,VU-IPC06
TRC-02
RECHARGEABLE&PORTABLE INTERMITTENT PNEUMATIC COMPRESSION (Model: VU-IPCU6)
Air Pressure Therapy System
DC Compression Machine:VU-IPC04B,VU-IPCS4,VU-IPCS6,VU-IPCS8,VU-IPCA8,VU-IPC05,VU-IPC05B
Cuffs:ACF-04, WCF-04, LBT-04, SPT-04, ACF-06, WCF-06, LBT-06, SPT-06, LPT-06, ACF-08, WCF-08, LBT-08, SPT-08, LPT-08
Medical Parallel Transport Bed: CM-ETB-2NG, CM-ETB-2ND;
Medical parallel transport beds : XW-PTB-8S;
CM-EHB-7NG, CM-EHB-7NH, CM-ENB-02, CM-ENB-03
Electric Hospital Bed: CM-AHB-3MA, CM-AHB-3MD, CM-AHB-6MB, CM-AHB-6MC, CM-AHB-6ME, CM-AHB-8MH, CM-EHB-5ND, CM-EHB-5NE,
Air Pressure Therapy System (VU-IPC04B)
Hand Rehabilitation Device (Model: SL-FR01)
Hand Rehabilitation Device (Model: SL-FR01S)
Hand Rehabilitation Device (Model: SL-FR03)
Hand Rehabilitation Device (Model: SL-FR02)
Hand Rehabilitation Device (Model: SL-FR02MS)
Circul8 Luxe
Air Pressure Therapy System (Model: VU-IPC06)
Air Pressure Therapy System (Model: VU-AMP01)
Air Pressure Therapy System, Item No.VU-NIPC02H, VU-IPC04H, VU-IPC06H
Air Pressure Therapy System (Model: VU-IPC12)
Air Pressure Therapy System (Model: VU-IPC04)
Air Pressure Therapy System (Model: VU-IPC03)
Air Pressure Therapy System (Model: VU-IPC01)
Air Pressure Therapy System (Model: VU-NIPC02)
Air Pressure Therapy System (Model: VU-AMP02)
Air Pressure Therapy System (Model: VU-IPC02)
Air Pressure Therapy System (Model: IPC06)
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)