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Everlife Medical Equipment Co., Ltd.: FDA-registered device maker in New Taipei City, Taiwan, 4 510(k) clearances

Everlife Medical Equipment Co., Ltd. is registered with the FDA (registration 3004753827) in New Taipei City, Taiwan. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated November 27, 2007. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number
3004753827
Address
8F, No. 8, Lane 235 Bao-Qiao Road, Xin-Dian District, New Taipei City, Taiwan, 23145
Owner or operator
EVERLIFE MEDICAL EQUIPMENT CO., LTD. (9066394)
Roles
Contract manufacturer, Exporter to the US, Manufacturer
First device listed
December 2, 2007
Registered through
2027
Brand names listed
Dysphagia Therapy Unit, EVERLIFE, Electrode Lead Wires, Flex-IT, Flex-MT, Flex-TENS

Devices it lists

DeviceProduct codeClassRoleSource
Cable, ElectrodeIKD2Exporter to the USaccessdata.fda.gov
Electrode, CutaneousGXY2Exporter to the US, Manufactureraccessdata.fda.gov
Interferential Current TherapyLIH2Contract manufacturer, Manufactureraccessdata.fda.gov
Stimulator, Muscle, PoweredIPF2Contract manufacturer, Manufactureraccessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain ReliefGZJ2Contract manufacturer, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 27, 2007K071624EVERELIFE TRANSCUTANEOUS MUSCLE STIMULATORGZJSubstantially EquivalentEverlife Medical Equipment Co., Ltd.accessdata.fda.gov
August 17, 2007K071320EVERLIFE POWERED MUSCLE STIMULATOR, MODEL E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-201311IPFSubstantially EquivalentEverlife Medical Equipment Co., Ltd.accessdata.fda.gov
June 29, 2007K070890EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507LIHSubstantially EquivalentEverlife Medical Equipment Co., Ltd.accessdata.fda.gov
May 13, 2005K050788EVERLIFEGXYSubstantially EquivalentEverlife Medical Instrument Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated November 27, 2007. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.