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Life-Tech Intl., Inc.

Also registered as Life-Tech, Inc.

United StatesFDA applicant, unverified

Devices
82

What Life-Tech Intl., Inc. makes

Life-Tech Intl., Inc. manufactures disposable and reusable medical devices for urodynamic testing, including catheter sets and pressure monitoring modules, as well as diagnostic tools for vestibular assessment, such as optokinetic and calorific irrigators. Their portfolio also includes iontophoresis and iontophoretic application devices, urodynamic pumps, and specialized culture media for medical use. Additional products cover dental appliances like dentaphors and stimulators for neurological testing.

The company’s devices are classified under FDA categories Class I, Class II, and Unclassified (U), with many authorised through the 510(k) pathway. These products are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue82

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  • Disposable Urodynamic Catheter Set Ref K896784

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • 5031 Bright Flash Stimulator Ref K822915

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Model 6110B Dentaphor Ref K870118

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Echobright Ref K111355

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • 1424 Tumistore Ref K822914

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Model 3000C Caloric Irrigator Ref K813552

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Prolong Ref K081864

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Urolab Janus Ref K904386

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Probloc, Hn Series And Prolong, Pl Series Ref K050499

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Model 5400 Optokinetic Stimulator Ref K822917

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Model 1858 Cavro/Pressure Module Ref K872077

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vesiscan Ref K093485

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Contistim Continuous Stimulating Catheter Nerve Block Set Ref K052954

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Prolong-Ex, Models: Plex-50CS, Plex-100CS, Plex-150CS Ref K072050

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Prolong, Models PL50, PL100, PL150 Ref K001129

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Modified F-10 Culture Medium Ref K923634

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Modified Use For Model 6110A Iontophoretic Appli. Ref K871869

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Uropump Model 1711 Ref K843224

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Urocomp Model 1404 Ref K821939

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • 5010 Visustim Ref K822919

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Volume Transducer Ref K931282

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Microflo Ref K904557

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Model 1350 Urodynamic Waveform Processor Ref K863167

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Dulbecco's Phosphate Buffered Saline Ref K923652

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Anorectal Manometry Software Option Arm-1 Ref K082056

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Model 6110 Iontophoretic Applicator Ref K863166

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Video Urodynamics Sys 1906B-Y & 1906C-Y Ref K843198

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ez Stim Ref K954505

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Urolab Spectrum Ref K931179

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Peripheral Nerve Block Support Tray Ref K073187

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Liquid Detector Ref K903495

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • 1870T Pressure Transducer Pre-Amplifier, 1880 Wate Ref K850602

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Danplex Diagnostic Audiometer, Clin. Diag. Audiomt Ref K923071

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Cavropump Ref K871129

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Urethralpressure Profile Catheter Ref K915484

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ear-A-Gator Ref K946108

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Urocomp Remote Control 1804 Ref K822916

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Handtymp Ref K923072

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Tumistore Recorder 1311 Ref K831252

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Model 1101M & 1151M Urolab Micro Urodynamic Record Ref K863168

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ezono 3000 Ref K120234

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Distilled Water Ref K923651

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Automatic Tympanometer Ref K923073

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Pvc Abdominal/Rectal Pressure Catheter Ref K954315

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Maxistim Ref K955031

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Probloc Insulated Needles Ref K926349

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Model Sk-14 Starter Kit For Dental Iontophoresis Ref K872039

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Danplex Screening Audiometer Ref K923074

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Mercury Rhinomanometer Ref K902120

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • 5012 Parabolic Stimulator Ref K822923

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-50 of 82

Showing 1-50 of 82

Frequently asked questions

How many devices does Life-Tech Intl., Inc. have in the registry?

The registry currently lists 82 devices for Life-Tech Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Life-Tech Intl., Inc.'s devices?

Among its 50 most recently registered devices, Life-Tech Intl., Inc. has devices listed in FDA 510(k) (50 devices).

What risk classes do Life-Tech Intl., Inc.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Life-Tech Intl., Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Life-Tech Intl., Inc. in the registry?

The most recently registered devices listed for Life-Tech Intl., Inc. include DISPOSABLE URODYNAMIC CATHETER SET, 5031 BRIGHT FLASH STIMULATOR, MODEL 6110B DENTAPHOR and ECHOBRIGHT.

Generated automatically from registry data and not verified by a human reviewer.