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Data / Medical devices / Hong Kong / Healthcare Technology International Ltd.

Healthcare Technology International Ltd.: FDA-registered device maker in Shek Mun, Shatin, Hong Kong, 14 510(k) clearances

Healthcare Technology International Ltd. is registered with the FDA (registration 3008959444) in Shek Mun, Shatin, Hong Kong. It lists 16 device types. The FDA files 14 510(k) clearances under its listings, the newest dated September 12, 2024. Registered through 2026. FDA data exported November 3, 2026.

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Get makers like this oneWatch Healthcare Technology International Ltd.
FDA registration number
3008959444
Address
Units 15-21, 12/F, Topsail Plaza, 11 On Sum Street, Shek Mun, Shatin, Hong Kong, --
Owner or operator
HEALTHCARE TECHNOLOGY INTERNATIONAL LTD. (9058334)
Roles
Exporter to the US
First device listed
May 21, 2009
Registered through
2026
Brand names listed
AccuTab, Accuryn Monitoring System, Accuryn Monitoring System; Accuryn SmartFoley IAP UO Temp Tray System; Accuryn SmartFoley UO Temp Tray System, Accuryn SmartFoley IAP UO Temp Tray System, Accuryn SmartFoley UO Temp Tray System, G3PRO, Theragun Elite, Theragun PRO PLUS and more

Devices it lists

DeviceProduct codeClassRoleSource
ArthroscopeHRX2Exporter to the USaccessdata.fda.gov
Catheter, Retention Type, BalloonEZL2Exporter to the USaccessdata.fda.gov
Dermal Cooling Pack/Vacuum/MassagerOOK2Exporter to the USaccessdata.fda.gov
Device, Pressure ApplyingKNM1Exporter to the USaccessdata.fda.gov
Enzymatic Esterase--Oxidase, CholesterolCHH1Exporter to the USaccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Exporter to the USaccessdata.fda.gov
Intra-Abdominal Pressure Monitoring DevicePHUUExporter to the USaccessdata.fda.gov
Lamp, Infrared, Therapeutic HeatingILY2Exporter to the USaccessdata.fda.gov
Massager, Powered Inflatable TubeIRP2Exporter to the USaccessdata.fda.gov
Massager, Therapeutic, ElectricISA1Exporter to the USaccessdata.fda.gov
Medical Device Data SystemOUG1Exporter to the USaccessdata.fda.gov
Oximeter, WellnessPGJ2Exporter to the USaccessdata.fda.gov
Pack, Hot Or Cold, ReusableIME1Exporter to the USaccessdata.fda.gov
Pad, Heating, PoweredIRT2Exporter to the USaccessdata.fda.gov
UroflowmeterEXY2Exporter to the USaccessdata.fda.gov
Warmer, Thermal, Infusion FluidLGZ2Exporter to the USaccessdata.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
September 12, 2024K233732CoolSculpting Elite SystemOOKSubstantially EquivalentZeltiq Aesthetics, Inc. (Acquired by Allergan Aestheticsaccessdata.fda.gov
January 13, 2023K221020Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 FEZLUnknownPotrero Medical, Inc.accessdata.fda.gov
October 4, 2021K211745RecoveryAir PROIRPSubstantially EquivalentTheragun, Inc.accessdata.fda.gov
April 16, 2020K200729HydroCision SpineJet SystemHRXSubstantially EquivalentHydrocision, Inc.accessdata.fda.gov
June 5, 2019K190804HydroCision TenJet DeviceHRXSubstantially EquivalentHydrocision, Inc.accessdata.fda.gov
April 15, 2016K153655Accuryn Monitoring SystemEZLUnknownPotrero Medical, Inc.accessdata.fda.gov
January 26, 2015K142491ZEL TIQ CoolSculpting SystemOOKSubstantially EquivalentZeltiq Aesthetics, Inc.accessdata.fda.gov
March 11, 2014K133483PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK FOR OTC USEIRPSubstantially EquivalentPortable Therapeutixaccessdata.fda.gov
May 2, 2012K120023ZELTIQ COOLSCULPTINGOOKSubstantially EquivalentZeltiq Aesthetics, Inc.accessdata.fda.gov
March 14, 2012K112902ENFLOW IV FLUID WARMERLGZSubstantially EquivalentVital Signs, Inc.accessdata.fda.gov
August 24, 2010DEN090002ZELTIQ AESTHETICS DERMAL COOLING DEVICEOOKUnknownZeltiq Aestheticsaccessdata.fda.gov
September 16, 2003K032529HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CURETTE, MODELS 51300, 51310HRXSubstantially EquivalentHydrocision, Inc.accessdata.fda.gov
November 24, 2000K002764HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURRHRXSubstantially EquivalentHydrocision, Inc.accessdata.fda.gov
July 24, 1990K901900L.D.X LIPID MONITORING SYSTEMCHHSubstantially EquivalentCholestech Corp.accessdata.fda.gov

Compare with other makers

Updated September 12, 2024. 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.