FDA Registration
Active
🇨🇳 China
XIAMEN HEALTHPAL ELECTRONIC CO,.LTD.
Reg #: 3014977697
·
FEI: 3014977697
·
Expires 2026
Products
3
Proprietary Names
28
Establishment Types
2
Classifications
3
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Registration Details
- Registration Name
- XIAMEN HEALTHPAL ELECTRONIC CO,.LTD.
- Registration Number
- 3014977697
- FEI Number
- 3014977697
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2F-4F-5F, No.1019-2, Wanjiachun Road, Torch High-Technic Zone (Xiang'an), Industrial Park
- City
- Xiamen Fujian
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K211850
Owner / Operator
- Firm Name
- Xiamen Healthpal Electronic Co,.Ltd.
- Operator Number
- 10060779
- Address
- 2F-4F-5F, No.1019-2, Wanjiachun Road, Torch High-Technic Zone (Xiang'an), Industrial Park
- City
- Xiamen
- State
- Fujian
- Postal Code
- 361100
- Country
- CN
- Correspondent
- Vilin Lin
US Agent
- Business Name
- Brij Strategic Consultations, LLC
- Contact Name
- Mukesh Kumar
- Address
- 610 Professional Dr, Suite 103
- City
- Gaithersburg
- State
- MD
- ZIP
- 20879
- Country
- US
- [email protected]
- Phone
- 240 7504893
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Massager, Powered Inflatable Tube | IRP | Class 2 | Physical Medicine | No | 2022-03-04 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2019-06-22 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2023-07-12 |
Proprietary Names
Air compression leg massager (FE-7208MD); FE-7216, AJLELM24, FE-7211, FE-7621, AJHDM22, AJACLRSP-L10, AJACLRS-L9; FE-7228;
FE-7107,FE-7108,FE-7106,FE-7231,FE-7322
FE-7230 FE-7230-5H FE-7240 FE-7206 FE-7401H FE-7320 FE-7232 FE-7321; FE-7236K, FE-7229, FE-7227, FE-7320, FE-7230, FE-7251,
FE-7407, FE-7221RK, CF-5208H, FE-7204B-CPL; FE-7237K FE-7306 VT-67223 FE-7309; FE-7271,FE-7270; HANMAX FE-7204B
Air compression massager (FE-7205, AJACCM23, FE-7213, AJLM22, FE-7214); B0DJW1J2ZN G1-DW9H-5IJO;
Air compression leg massager (FE-7204B)
Air compression massager (AJFLM22, FE-7109, AJSKM23, AJCACCM23, AJCLM23, AJFLWM23)
massager, powered inflatable tube - Air C; Air compression leg massager (FE-7126, FE-7302, FE-7304, FE-7113, FE-7113A, FE-7117)
FE-7206,FE-7207,FE-7208,FE-7209, FE-7210, FE-7212,FE-7115, FE-7221; FE-7204A, FE-7204, FE-7204C; Air compression leg massager (FE-7205);
Air compression leg massager (FE-7203, FE-7203A, FE-7203B, FE-7202, FE-7202A, FE-7202B; Air compression leg massager (FE-7204B);
Air compression leg massager (FE-7204B); Air compression leg massager (FE-7301); Air compression leg massager (WELOV L500, WELOV L700);
Heating Massager Mat; Massage Mattress; Household Partial Electric Massager; Massage Pillow; Massager; Massager Fit Roller Vibrating Sport Recovery
FE-3228 FE-3310 FE-0164S FE-0164PS FE-0171 FE-4006-1 FE-0158 FE-0158V FE-0180 FE-0180V FE-5316 FE-5310;
Pulio PB001WH; Pulio P004S, Pulio H001, Pulio N001, Pulio P005, Pulio P003, Pulio P004BK
Deep4s FE-5868; Dextra FE-0152; Electric; Eye massage; Foot Massage FE-5311, AJFTM22
massager, therapeutic, electric - CF-1407-CPL, CF-4503-SL, FE-0151, FE-0151S, FE-3006B
P004, N002, PB001, PB001BK, PB001WH; PLO-CB227, HD002, FE-7130, FE-7129, FE-7124
FE-7108 FE-7125 FE-7502 FE-3309 FE-5902; FE-7116, FE-7127; Foot Warmer; Foottopia FE-3238; Hand Massager;
FE-3307 FE-3311 FE-0145 FE-0162 FE-0163 FE-0158 FE-5502 FE-5909 FE-5315 FE-7125 FE-5313 FE-4501 FE-4060V FE-3005 FE-4015;
Foot Massager; EYE C FE-4619,FE-0161,FE-0162,FE-0134,FE-0148,FE-4019,FE-4500,FE-0163; FE-0004; FE-0153, FE-4006, FE-7308PL;
PulseMax FE-5848; Shiatsu Massager; Therapeutic; Yoga Massager, FE-5862
Massager Gun; MB-201;; Neck Massager; Oculax eye massager; P004S, H001, N001, P005, P003, P004BK, P004BKS;
Pulio P004BKS, Pulio P004, Pulio N002, Pulio PB001, Pulio PB001BK; FE-2004,FE-5902,FE-7105;
Household Partial Electric Massager
FE-0186,FE-0182,FE-5504
lamp, infrared, therapeutic heating - FE-7505, FE-7601, FE-7602, FE-7603, FE-7604, FE-7605, FE-7606, FE-7607, FE-7608;
FE-7505NK; FE-7509; Infrared and Red Light Therapy Wrap, FE-7108
Infrared and Red Light Therapy Wrap
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device