XIAMEN HEALTHCARE ELECTRONIC CO.,LTD.

FDA Device Registration & Listing · Xiamen Fujian, CN · Registration 3008840106

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008840106
FEI Number
3008840106
Entity Name
XIAMEN HEALTHCARE ELECTRONIC CO.,LTD.
City/State/Country
Xiamen Fujian, CN
Establishment Address
65-66#,62-63#Building,Siming Zone, Tongan Industrial District, Xiamen Fujian 361100, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
XIAMEN HEALTHCARE ELECTRONIC CO.,LTD. (Owner Number: 10057418)
Owner / Operator Contact Address
65-66#,62-63#Building,Siming Zone, Tongan Industrial District, Xiamen, CN-FJ 361100, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

SNS,SNS-24,ES-1321A, ES-1321B Osaki,Emperor 4D II,EC-8606G Joypal,JP5652,EC-5652A BODYFRIEND,BFX-2110US,OI-2219B Brookstone,BK-650,EC-7507B FIORI,Fiori Signature,ES-1340A,ES-1340B AmaMedic,AM-3D Pro Tecno,EI-6501A Osaki Japan,JP-NEXUS 4D,EC-8607B Brookstone,BK-150,EC-375D Osaki,OS-Pro Alpina,EC-624H Titan,4D signature,EC-8610E CUCKOO,"CMS-H10BR,CMS-H10BE",EC-806C cozzia,CZ-388,EC-388Z Osaki,Maxim 3D LE,EI-8502A Osaki,Galaxy,EC-563,EC-363H Osaki,Osaki OS- Diva II,ES-1310E Mynta,MC5100,EC-5651D cozzia,CZ-710,EC-628M OGAWA,OG6250,EC-625B Osaki,OS-3D Pro Cyber 2,EC-381G Osaki,OS-Pro Soho 2,EC-626E Osaki,OS-Honor,EI-8601B massage ergotec,ET-300,EC-7502A Titan,Optimus 3D,EI-5501C Osaki Platinum,OP-4D Master,EI-8701F cozzia,CZ-640,EC-218E Osaki,Osaki 4000XT,EC-3205A,EC-3205H ergotec,EC-360D,EC-360D LUMI,LUMI-YUME,OGI-2203B Osaki Platinum,OP-Xrest 4D,EI-8701C cozzia,CZ-357,EC-3202D Osaki,OS-7700R,EC-325R Osaki,TI-Pro Alpine,EC-621C human touch,Gravis,AG-6800A OGAWA,OG8801,EC-628Y2 ANS,ans-p20B,ES-1315A Osaki,Osaki Pro Maestro,EC-806A Bodyfriend,BFX-2000US,OGI-2210A Titan,Itech Unicas,ES-1314B Osaki,4D Orion Duo Mech ,EC-5623A;Osaki,4D Manhattan Duo Mech,EC-8507B;FIORI,Fiori Omni,ES-1340D; Osaki,Lusso XT-2 Leather,Lusso XT-1,AG-6006A cozzia,CZ-630,EC-617D OGAWA,OG7010,EC-802T Osaki,OS-3D Pro Cyber,EC-381E Osaki,OS-Hiro LT,EI-8602A cozzia,CZ-800/Quantum,EC-638B;OGAWA,OG5600/Refresh 3D,EC-1612A;SVAGO,SV-700,EQ-S202A; SVAGO,SV-701,EQ-S203A;SNS,SNS-25,ES-1322A;FUJIIRYOKI,MR6000,EC-5503B; OGAWA,OG5500,EC-3213B Osaki,OS-7200H,EC-385P Osaki,Osaki Pro Admiral,EC-7506B Osaki,OS-Bello,OGI-2206B Titan,Titan Pro-3D Prestige,EI-6501C cozzia,EC-670,EC-618G Osaki,Osaki-Pro 3D Prestige,EI-6501A Osaki,Glaxy Salon 2,EC-356E Osaki,Sonno XT-2 Leather,AG-6006A Brookstone,BK-550,OI-3310A FIORI,FIORI8000,EC-380Y Osaki,Osaki-4D Maestro LE 2,EC-806R Osaki,OS-3D Aspire,EC-3622A Cozzia,CZ-390,Fusion Pro,EC-1227A EC-5503B,MR6000 Titan,VC24,ES-3218D OGAWA,OG8900,EC-7610A ANS,ans16,EC-347A, EC-347B Osaki,Osaki Pro-Primo,ES-1310A Mynta,M1710,EC-6261E OGAWA,OG8100,EC-528Z2 ANS,ans-p20C,ES-1315B Osaki,Osaki Pro Maestro 2,EC-806C Bodyfriend,BFX-7000US,EC-7501B Titan,Itech Lexi,ES-1314C NSS,NSS-26,ES-1321C Osaki,OS-Unicus,ES-1314A Osaki,Osaki OS-3D Opulent,EC-7513A BODYFRIEND,BFX-2001US,OI-2210H cozzia,CZ-710V,EC-628M1 Homedics,HMC-500,EC-375D Osaki,OS-3D Otamic LE,OI-3300C,OI-3300J,OI-3300J FUJIIRYOKI,MR600,EC-5503A Osaki,OS - Ai 3D Envy,EC-7516E AmaMedic,Juno II 3D,EC-3609A;Osaki,3D Monarch LE,EC-3626G;Osaki,OS-3D Vito,EC-3628G; cozzia,CZ-711,EC-628M2 Osaki,Galaxy-Crown,EC-260D Osaki,Sonno XT-2 Leather,Sonno XT-1,AG-6006B ANS,ans21,ES-2010A Osaki,Osaki OP-O6,ES-1310B Mynta,MC2100,EC-3223H cozzia,EC-618,EC-618F AmaMedic,Pro-Prestige 3D,EI-6501A Osaki,Galaxy,EC-555,EC-355G,EC-355K Osaki,Sonno XT-1,AG-6006A Fujiiryoki human touch,Aerem,ES-2010C Brookstone,BK-750,EC-7510A LUMI,LUMI-KUMO,OGI-3210F Osaki Platinum,OS-AI VERA 4D+,EC-6262J Osaki Platinum,4D-Escape Duo,EC-8638A cozzia,CZ-715,EC-628Y1 Osaki,APEX-V1,EC-342A Osaki,OS-Pro Summit,EC-621F Osaki,OS-Pro 3D Tecno,OI-3300L OGAWA,OG9000,Biovision,EC-638H Human Touch,AirTech ZG PRO,AG-6000M OGAWA,OG8802,4D Fusion Master Drive,EC-6700E Cozzia,CZ-718,Qi XE Pro Duo,EC-6700A Brookstone,BK-450,EI-5502A FIORI,FIORI9000,ES-650K,ES-650K(1) Osaki,OS-Pro Soho,EC-626B,EC-626F Osaki,OS Pro-3D Sigma,EC-7512A Osaki,Lusso XT-2 Leather&Lusso XT-1,AG-6006A Therabody,Lounger,AG-6005A Osaki,Osaki OS-Primo 2,ES-1310C Real Relax,PS6500,EC-6602G,EC-6602H Mynta,MC4100,EC-6263E Mynta,1620,EC-1212A;Mynta,1630,EC-1215A;RELAX THE BACK,HALE Premier,AG-6000M; Osaki Platinum,Somnus 4D DuoFlex AI,EC-6701A Titan,Arcadia 3D LE,EC-1621B SNS,SNS-25,ES-1322B MYN,MC1650,EC-1233A SNS,SNS-21,ES-1320A, ES-1320B Ador,Emperor 4D,EC-8606J Osaki,Osaki OS-Lulu V,ES-1310D Joypal,JP5651,EC-5651A BODYFRIEND,BFX-3000,EC-6606A OGAWA,OG8800,EC-628Y ANS,ans-p20,EC-349H Osaki,OS-Pro Pinnacle,EC-385P(2) Osaki,Osaki Pro Admiral II,EC-7506E,EC-7506Q Otamic,Otamic-2X,OGI-2213B Osaki,Osaki-Vista,EC-3211A Osaki,4D Yoga Flex;EC-6607B Cozzia,CZ-712,Qi SE Duo,EC-6700B CUCKOO,CMS-H10BR,CMS-H10BE,EC-806C Osaki,3D Solo Flex,EC-3711B OGAWA,OG6400, Active XL Duo,EC-1627B Osaki,Milan,EC-1132C Osaki,4D Yoga Flex,EC-6607B Osaki Platinum,Pinnacle 5D DuoFlex AI,EC-8639A SVAGO,SV-635,AG-6003A Osaki,OS-Pro Maxim,EC-624C Titan,Titan-Aurora,EC-3208B Osaki,OS - Bliss II,EC-1132A cozzia,CZ-681,EC-802V SVAGO,SV-630PU,AG-6002B Osaki,OS-4000LS,EC-623B AmaMedic,AM-Juno II,EC-3209K Osaki,Emperor II,EC-8606S OGAWA,OG7500,EC-7505B Osaki,OS-7200CR,EC-385H Osaki,Osaki Pro Yamato,EC-629B Osaki,Osaki OS-Champ,OGI-3210G OGAWA,OG8901, Master Drive Duo LE,EC-7610C cozzia,CZ-716,EC-628Y3 SVAGO,SV-395,AG-6000J Osaki,APEX-V2,EC-342B Osaki,OS-Pro Omni,EC-622B Titan,Titan Pro-Prestig,EI-6501C cozzia,CZ-680,EC-802M SVAGO,SV-630,AG-6002A Osaki,OS-4000CS,EC-623A AmaMedic,AmaMedic-Premium,EI-6501F OGAWA,OG1000,Ogawa Nova,EC-1131C Osaki,3D Day Dream,M13059TA00-US,M13059TA01-US cozzia,CZ-328,EC-328B cozzia,CZ-7505,EC-7505B Osaki,OS-4000T,EC-380N Osaki,Osaki OP-O4,ES-1312A Cozzia,CZ-650,Zen Duo,EC-5552D Cozzia,CZ-646,Twin Tech,EC-7502E cozzia,CZ-641,EC-218D Osaki,TI-7700,EC-325B Osaki,OS-3D Pro Dreamer,EC-385T,EC-385T(1) cozzia,AG-7150/Hale Premiere,AG-6000M SVAGO,SV-200,AG-6150A Osaki,OS-4500CS,EC-623F Titan,TI-Pandora,EC-3209M cozzia,CZ-322,EC-322I cozzia,AG-7100R,AG-6000G,AG-6000L AmaMedic,HiLux,EC-8606B Osaki,OS-4000,EC-380D,EC-380P Osaki,Osaki OP-O5,ES-1311A Osaki,4D Solo Flex,EC-3711B SNS,Miley III,ES-1361A Titan,Zena,ES-3218D1 Cozzia,CZ-335, Bliss ProFlex,EC-1212D Osaki,3D 4000LE,EC-5653A Osaki Platinum,4D Vanguard Duo,EC-8639B Osaki Platinum,Hypnos 4D Pro AI;EC-6701B CUCKOO,CMS-E410CP/CMS-E10D/CMS-E10DCG/CMS-E10DCP,C16869SW02-US Osaki Platinum,Somnus 4D DuoFlex AI;EC-6701A Osaki,3D Quest,EC-1616C Osaki,Pro Vivant 5D,EC-6706A Osaki Platinum,Pinnacle 5D DuoFlex AI;EC-8639A Accessory, cal apparel

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2018-04-03
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2020-05-06

Official Correspondent

Cui Pengfei

US Agent Details

ZHENG XU Email: cathygeng2007@gmail.com Phone: (248) 5508758

Related Public Records

Same Entity

XIAMEN HEALTHCARE ELECTRONIC CO.,LTD.
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008840106. Last updated year: 2026. Please use registration number 3008840106 when referencing this establishment in official correspondence.
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