Questionable Device Index | Quackwatch
Time 2022-08-16 17:19:15Web Name: Questionable Device Index | Quackwatch
WebSite: http://www.devicewatch.org
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Questionable Device Index
November 29, 2017
In the United States, medical devices are regulated primarily by the Food and Drug Administration. Federal law require that all devices be safe and effective for their intended use and that new devices have premarket clearance or approval. The current classification system considers (a) the extent to which use of the device involves matters of life or death or serious injury and (b) whether the device is entirely new or is similar to a device that has been cleared or approved. Simple devices, like bandages and tongue depressors do not require special approval, but the vast majority of devices used for diagnosis and treatment do require approval.
The devices listed on this page are either inherently bogus or were cleared or approved for one use but improperly used for other purposes. A few have gained FDA clearncce based on “substantially similarity” to previously cleared or approved devices, even though they are actually intended to be used for unapproved purposes. For example, some bogus devices have been approved as “biofeedback” instruments even though their actual intended use is to diagnose and/or treat disease. Devices that have been cleared are listed in the FDA’s 510(k) database, which can be searched online. It is often useful to check because some marketers claim that their devices are cleared or approved when they are not..
General Information
Signs of A Quack DeviceDevices Promoted with False and/or Misleading Claims
Activator Adjusting InstrumentAladdin H TR-1000 and TR-2000Alex Chiu’s Immortality DeviceAmalgameterAqua Detox/ Ionic CleansingAtlas orthogonal percussion instrumentBio-Electric Field Enhancement (BEFE)BioEnergy Light Therapy SystemBio-Ionic System (Evans Rapsomanikis)Bio-Lyfe Immune BoosterBioPhotonic ScannerBioray Light and Sound Generator (link to FDA warning letter)BiotapeBody VibesBrain Wave SynchronizersBTA S-2000Cancer Detector LEC-03Cavitat ultrasonograph (link to another site)Chi MachineCTD-Mark I for Carpal Tunnel SyndromeCrystal Clear Electron Water/Air Machine (John Ellis)Detox Foot PadsDynatron (link to another site)E-Meter: [description] [federal regulatory action]E-Z DetoxEar CandlesEAV Devices: AccuGraph, Accupath 1000, Asyra, Avatar, BICOM, Bio-Scan SWA, Bio-Tron, Biomeridian, Computron, Dermatron, DiagnoMètre, Eclosion, e-Lybra 8, ELAST, Interro, Interactive Query System (IQS), LISTEN System, MORA, Matrix Physique System, Oberon, Omega Acubase, Omega Vision, Orion System, Phazx, Prophyle, Punctos III, Vegatest, Vieva Vital Analyzer, Vitel 618, and ZYTO. Some of these are referred to as “bioresonance” devices.EB-305 Energy BalancerElectromagnetic Field DetectorsElectronic Muscle Stimulators (some uses) (link to FDA consumer information)Ellis Micro-DynameterEnergetix Magnetic JewelryEndocardiograph (link to another site)F-ScanHealyHothouse FIR Health BuilderHuman Computer Network Interface (HCNI)I-Health EDA (Energy Data Acquisition) System (to be postedInfratonic 4.3InnerQuest Brain Wave SynchronizerIonic BreezeiTOViKimi insolesKirlian PhotographyLaser Facelifts (link to another site)Life Force Energy DiscsLight Beam Generator (LBG)Magnagraph Data Collection SystemMagnetic BraceletMagnetic MugMigun Thermal Massage BedMillennium Water CoolerMolecular Magnetic EnergizerNegative Ion Generators (link to another site)Nutri-Energetics Systems (NES)NutriPaxOberon (link to another site)OncoDiagnosticatorONDAMED Therapy SystemOrgone accumulatorsOzone generators (air cleaners)Pap Ion Magnetic Inductor (PAP-IMI)Photon GenieQ-Ray braceletsQ2 Energy SystemQe3 Quantum Energy OscillatorQuantron Resonance System (QRS)Quantum Xrroid / SCIO/ EPFXReBuilder™Reflexology Steering Wheel CoverRelax-A-CizorRife Frequency GeneratorRita MeterScalar LightScenar 97.4Sculptone Vacuum Therapy MachineSeaBands acupressure wrist bands (link to another site)Slim SlippersSmarty Whole Body Hyperthermia SystemSpectro-ChromeSpinal Analysis MachineSpinal heat-detecting devices (handheld): Analagraph, Neurocalometer, Nervo-Scope, Nervoscope, Temp-o-ScopeStimulation VII (breast developer)The StimulatorSyncrometerTeslar watchesTheratecToftness Radiation DetectorTransfer Enhancement AmplifierVegatestV.I.B.E. (Vibrational Integration Bio-photonic Energizer)Water Testing ScamsWobble ChairZ-Strong Blood Pressure DepressorZapperZoetronGeneral Information on Other Web Sites
Aquascams (Water-related scams and quackery)Bakken Library and Museum: Quack devicesMisleading Advertisements for Home-Use DevicesMuseum of Questionable Medical DevicesDr. Bob’s Home Page for Medical QuackeryQuack Medicine: Imagination Goes WildQuackatoriumQuestionable Devices for CancerRadioactive Quack CuresThis article was revised on April 10, 2020.
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