FDA Registration
Active
🇨🇳 China
Homedics,HMC-500,EC-375D
Reg #: 3008840106
·
FEI: 3008840106
·
Expires 2025
Products
1
Proprietary Names
171
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- XIAMEN HEALTHCARE ELECTRONIC CO.,LTD.
- Registration Number
- 3008840106
- FEI Number
- 3008840106
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 65-66#,62-63#Building,Siming Zone, Tongan Industrial District
- City
- Xiamen Fujian
- Country
- CN
Owner / Operator
- Firm Name
- XIAMEN HEALTHCARE ELECTRONIC CO.,LTD.
- Operator Number
- 10057418
- Address
- 65-66#,62-63#Building,Siming Zone, Tongan Industrial District
- City
- Xiamen
- State
- Fujian
- Postal Code
- 361100
- Country
- CN
- Correspondent
- Cui Pengfei
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2018-04-03 |
Proprietary Names
Homedics,HMC-500,EC-375D
Osaki,OS-7200CR,EC-385H
Osaki,Osaki Pro Yamato,EC-629B
CUCKOO,"CMS-H10BR,CMS-H10BE",EC-806C
FUJIIRYOKI,MR600,EC-5503A
Brookstone,BK-150,EC-375D
Osaki,OS-3D Otamic LE,OI-3300C,OI-3300J,OI-3300J
Titan,4D signature,EC-8610E
cozzia,CZ-711,EC-628M2
FIORI,FIORI9000,ES-650K,ES-650K(1)
Osaki,OS-7200H,EC-385P
Osaki,Osaki Pro Admiral,EC-7506B
Osaki,Sonno XT-2 Leather,Sonno XT-1,AG-6006B
human touch,Aerem,ES-2010C
cozzia,CZ-357,EC-3202D
Osaki,Osaki Pro Maestro 2,EC-806C
cozzia,AG-7150/Hale Premiere,AG-6000M
SVAGO,SV-200,AG-6150A
Osaki,Emperor 4D II,EC-8606G
Osaki,Osaki OS- Diva II,ES-1310E
Titan,TI-Pandora,EC-3209M
cozzia,EC-670,EC-618G
Osaki,OS-4000LS,EC-623B
Osaki,Sonno XT-2 Leather,AG-6006A
cozzia,CZ-710V,EC-628M1
OGAWA,OG7500,EC-7505B
FIORI,Fiori Signature,ES-1340A,ES-1340B
Osaki,Osaki OS-Champ,OGI-3210G
Osaki,Lusso XT-2 Leather,Lusso XT-1,AG-6006A
cozzia,CZ-680,EC-802M
SVAGO,SV-630,AG-6002A
Osaki,Osaki OS-Primo 2,ES-1310C
AmaMedic,AmaMedic-Premium,EI-6501F
cozzia,CZ-710,EC-628M
OGAWA,OG6250,EC-625B
FIORI,FIORI8000,EC-380Y
Osaki,OS-Pro Soho 2,EC-626E
Osaki,OS-Honor,EI-8601B
CUCKOO,CMS-H10BR,CMS-H10BE,EC-806C
SVAGO,SV-701,EQ-S203A;SNS,SNS-25,ES-1322A;FUJIIRYOKI,MR6000,EC-5503B;
SNS,SNS-21,ES-1320A, ES-1320B
Ador,Emperor 4D,EC-8606J
Osaki,OS-4000T,EC-380N
Joypal,JP5651,EC-5651A
BODYFRIEND,BFX-3000,EC-6606A
cozzia,CZ-328,EC-328B
cozzia,CZ-7505,EC-7505B
Osaki,OS-Pro Alpina,EC-624H
Osaki,Osaki OP-O4,ES-1312A
SNS,SNS-24,ES-1321A, ES-1321B
Osaki,OS-3D Pro Cyber,EC-381E
Joypal,JP5652,EC-5652A
BODYFRIEND,BFX-2110US,OI-2219B
cozzia,CZ-640,EC-218E
Osaki,OS-Pro Pinnacle,EC-385P(2)
Osaki,Osaki Pro Admiral II,EC-7506E,EC-7506Q
Fujiiryoki
OGAWA,OG8800,EC-628Y
LUMI,LUMI-YUME,OGI-2203B
Otamic,Otamic-2X,OGI-2213B
Osaki,Osaki-Vista,EC-3211A
cozzia,CZ-715,EC-628Y1
Osaki,Osaki Pro-Primo,ES-1310A
cozzia,CZ-716,EC-628Y3
Osaki,Osaki OP-O6,ES-1310B
Titan,Titan Pro-Prestig,EI-6501C
Titan,Arcadia 3D LE,EC-1621B
cozzia,CZ-800/Quantum,EC-638B;OGAWA,OG5600/Refresh 3D,EC-1612A;SVAGO,SV-700,EQ-S202A;
OGAWA,OG8900,EC-7610A
ANS,ans16,EC-347A, EC-347B
Osaki,Osaki-Pro 3D Prestige,EI-6501A
Osaki,Glaxy Salon 2,EC-356E
Osaki,OS-Pro 3D Tecno,OI-3300L
Mynta,M1710,EC-6261E
Osaki Platinum,4D-Escape Duo,EC-8638A
cozzia,AG-7100R,AG-6000G,AG-6000L
SVAGO,SV-635,AG-6003A
Osaki,OS-Unicus,ES-1314A
Titan,Titan-Aurora,EC-3208B
Osaki,OS - Bliss II,EC-1132A
cozzia,CZ-681,EC-802V
SVAGO,SV-630PU,AG-6002B
Osaki,Osaki OS-Lulu V,ES-1310D
AmaMedic,AM-Juno II,EC-3209K
Brookstone,BK-550,OI-3310A
Osaki,Osaki 4000XT,EC-3205A,EC-3205H
Osaki,Osaki-4D Maestro LE 2,EC-806R
Osaki,OS-3D Aspire,EC-3622A
OGAWA,OG5500,EC-3213B
LUMI,LUMI-KUMO,OGI-3210F
Osaki,OS-Bello,OGI-2206B
human touch,Gravis,AG-6800A
cozzia,CZ-641,EC-218D
Osaki,OS-3D Pro Dreamer,EC-385T,EC-385T(1)
Osaki,Osaki Pro Maestro,EC-806A
cozzia,CZ-322,EC-322I
Osaki,OS-Pro Maxim,EC-624C
Osaki,Osaki OP-O5,ES-1311A
Mynta,MC4100,EC-6263E
AmaMedic,Juno II 3D,EC-3609A;Osaki,3D Monarch LE,EC-3626G;Osaki,OS-3D Vito,EC-3628G;
EC-5503B,MR6000
Titan,VC24,ES-3218D
Cozzia,CZ-390,Fusion Pro,EC-1227A
OGAWA,OG9000,Biovision,EC-638H
ergotec,ET-300,EC-7502A
Osaki,APEX-V2,EC-342B
Osaki,OS-Pro Omni,EC-622B
Osaki Platinum,OP-4D Master,EI-8701F
Brookstone,BK-650,EC-7507B
Osaki,TI-7700,EC-325B
AmaMedic,AM-3D Pro Tecno,EI-6501A
Osaki Japan,JP-NEXUS 4D,EC-8607B
cozzia,EC-618,EC-618F
Osaki,Galaxy,EC-555,EC-355G,EC-355K
Osaki,OS-4000CS,EC-623A
Osaki,Sonno XT-1,AG-6006A
Cozzia,CZ-712,Qi SE Duo,EC-6700B
Brookstone,BK-450,EI-5502A
Osaki,Galaxy-Crown,EC-260D
Osaki,OS Pro-3D Sigma,EC-7512A
Osaki,Lusso XT-2 Leather&Lusso XT-1,AG-6006A
Brookstone,BK-750,EC-7510A
Osaki,OS-7700R,EC-325R
Osaki,TI-Pro Alpine,EC-621C
Titan,Titan Pro-3D Prestige,EI-6501C
Osaki Platinum,OS-AI VERA 4D+,EC-6262J
Osaki,OS - Ai 3D Envy,EC-7516E
Therabody,Lounger,AG-6005A
AmaMedic,HiLux,EC-8606B
Osaki,OS-4000,EC-380D,EC-380P
Real Relax,PS6500,EC-6602G,EC-6602H
ergotec,EC-360D,EC-360D
ANS,ans-p20,EC-349H
Osaki,APEX-V1,EC-342A
Osaki,OS-Pro Summit,EC-621F
Osaki Platinum,OP-Xrest 4D,EI-8701C
massage
OGAWA,OG8801,EC-628Y2
ANS,ans-p20B,ES-1315A
Titan,Optimus 3D,EI-5501C
Bodyfriend,BFX-2000US,OGI-2210A
Titan,Itech Unicas,ES-1314B
NSS,NSS-26,ES-1321C
Osaki,OS-3D Pro Cyber 2,EC-381G
Osaki,Osaki OS-3D Opulent,EC-7513A
BODYFRIEND,BFX-2001US,OI-2210H
cozzia,CZ-388,EC-388Z
Osaki,OS-4500CS,EC-623F
Mynta,MC5100,EC-5651D
cozzia,CZ-630,EC-617D
OGAWA,OG7010,EC-802T
Osaki,OS-Pro Soho,EC-626B,EC-626F
Osaki,OS-Hiro LT,EI-8602A
OGAWA,OG8100,EC-528Z2
ANS,ans-p20C,ES-1315B
AmaMedic,Pro-Prestige 3D,EI-6501A
Bodyfriend,BFX-7000US,EC-7501B
Titan,Itech Lexi,ES-1314C
SVAGO,SV-395,AG-6000J
ANS,ans21,ES-2010A
Osaki,Maxim 3D LE,EI-8502A
Osaki,Galaxy,EC-563,EC-363H
Mynta,MC2100,EC-3223H
Human Touch,AirTech ZG PRO,AG-6000M
Mynta,1620,EC-1212A;Mynta,1630,EC-1215A;RELAX THE BACK,HALE Premier,AG-6000M;
Osaki,4D Orion Duo Mech ,EC-5623A;Osaki,4D Manhattan Duo Mech,EC-8507B;FIORI,Fiori Omni,ES-1340D;
OGAWA,OG8802,4D Fusion Master Drive,EC-6700E
MYN,MC1650,EC-1233A
Cozzia,CZ-646,Twin Tech,EC-7502E
Cozzia,CZ-718,Qi XE Pro Duo,EC-6700A
Cozzia,CZ-650,Zen Duo,EC-5552D
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device