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This article applies to selling in: United States

Medical devices and accessories

Important: If you supply products for sale on Amazon, you must comply with all federal, state, and local laws and Amazon policies applicable to those products and product listings.

Examples of permitted listings for all sellers

  • Medical devices that are authorized by the Food and Drug Administration (FDA) for over-the-counter purchase that are not otherwise restricted and are appropriately described and labeled
  • Eyeglass frames
  • Tanning devices
  • Otoscopes
  • Ionized or ionic bracelets
  • Personal Sound Amplification Products (PSAPs)

Permitted listings for sellers participating in the Professional Health Care Program

Products that require a prescription or a medical professional's supervision or direction are considered "restricted" by Amazon and may only be sold to appropriately licensed healthcare customers who have Amazon Business accounts. If you are interested in selling your product in this way, please email prohealthcare@amazon.com to request more information about Amazon’s Professional Health Care Program.

Note: The following listings are prohibited for any seller not authorized to sell restricted medical products through the Professional Health Care Program.
  • Products that require a prescription or a medical professional’s supervision or direction for their use
  • Products that are labeled for professional use only or not for retail sale
  • Products that have been classified by the FDA as "Class I," "Class II," or "Class III" medical devices that require FDA clearance or approval that have not been cleared or approved by the FDA for over-the-counter use, such as:
    • Acupuncture/intradermal needles
    • Anesthetic vaporizers
    • Asthma inhalers
    • Bacteriostatic water
    • Cancer tests
      • See examples of cancer tests below.
    • Cardiac monitor
    • Cavity varnish
      • See examples of cavity varnish below.
    • Chin-up strip
    • Circumcision devices
    • Contact lens cases (unless approved for over-the-counter use)
    • Contact lenses, including both cosmetic and corrective lenses.
    • Continuous, Variable and Bilevel Positive Airway Pressure (CPAP, VPAP, BiPAP) devices and certain accessories
      • See examples of Continuous, Variable and Bilevel Positive Airway Pressure (CPAP, VPAP, BiPAP) devices and their accessories below.
    • Cranial electrotherapy stimulators
    • Defibrillators (unless approved for over-the-counter use)
      • See examples of prohibited defibrillators below.
    • Prescription dental devices, such as:
      • Dental burs
      • Dental X-ray units
      • Denture relining, repairing, or rebasing resin
        • See examples of denture relining, repairing, or rebasing resin below.
      • Dental handpiece or dental drill
    • Electrical Muscle Stimulation (EMS) units and their accessories
      • See examples of Electronic Muscle Stimulation (EMS) units and their accessories below.
    • Electronic Stethoscopes
    • Electrosurgical cutting and coagulation devices
    • Fetal dopplers
    • Home HIV test kits
      • With the exception of the Home Access HIV-1 Test System, which has been approved for over-the-counter use by the FDA
    • Hypodermic needles and insulin injectors, such as:
      • Monject Safety Syringes
    • Infant heel warmers
    • Implantable devices, such as pacemakers
    • Infusion pumps and their accessories (with exception of batteries, which are permitted)
    • Infusion set
    • Insulin
    • Insulin pumps
      • See examples of insulin pumps below.
    • Laser combs
    • Light therapy devices, such as:
      • Pain X
    • Mandibular advancement devices
      • See examples of mandibular advancement devices below.
    • Mesotherapy products
    • Nebulizers and their accessories, such as holding chambers
    • Oral cavity abrasive polishing agents
      • See examples of oral cavity abrasive polishing agents below.
    • Oxygen concentrators, compressors, conservers, generators, condensers and their accessories, such as:
      • Hyperbaric chambers
    • Penis enlargement devices
      • See examples of penis enlargement devices below.
    • Pinhole eyewear that makes unapproved medical claims
    • Prescription eyewear
    • Prescription toothpaste, such as:
      • Colgate PreviDent
    • Polar Care Cold Therapy System products manufactured by BREG
    • Pulse oximeters (unless marketed for "sports or aviation" use only or "not for medical use")
    • Radiesse
    • Resin tooth bonding agents
      • See examples of resin tooth bonding agents below.
    • Ringers solution
    • Seizure bite sticks
    • Skin glue
    • Surgical kits
    • Surgical sutures
    • Transcutaneous Electrical Nerve Stimulators (TENS) machines and their accessories
    • Ultra sound therapy and ultra sound pain relief devices
    • Vaginal pessary devices
    • Ventilator machines
    • Ventros Immunodiagnostic, Integrated, and Chemistry Systems

Examples of prohibited listings for all sellers

  • Products that have been altered to change the product's performance, safety specifications, or indications of use
  • Products that the Food and Drug Administration (FDA) has determined present an unreasonable risk of injury or illness, such as:
    • Ear candle
    • Zappers
  • Products for which a premarket notification is required but has not yet been filed
  • Products that have passed their expiration or "use by" dates
  • Products labeled as "tester," "not for retail sale," or "not intended for resale"
  • Certain medical devices regardless of FDA clearance or approval, such as:
    • Hearing aids (with the exception of hearing aid accessories, which are permitted)
  • Products that are marketed as unapproved or unregistered medical devices, such as:
    • Psoriasis lamps
  • Certain menstrual cups, such as:
    • Monzcare R-cup and LadyCup
    • Rainbow and iCare menstrual cups
  • Products that have been the subject of criminal enforcement, injunctions, seizures, or warning letters, such as:
    • Lelo LunaBeads and Tor II
    • WaxVac Ear Cleaners
  • Products that incorporate Class IIIB lasers (such as laser light show projectors) and Class IV lasers (for example, industrial lasers)
  • Listings claiming that a product is intended to be used for the diagnosis, cure, mitigation, treatment, or prevention of disease in humans unless the claim is cleared or approved by the FDA, such as:
    • Chelation products, including metal detection test kits
      • See examples of chelation products below.
    • Miracle Mineral Solutions
    • Rife Machines
    • Sexually Transmitted Disease (STD) Test Kits
    • Testosterone test kits
  • Products that are adulterated or misbranded
  • Products that contain mercury, such as thermometers and batteries
  • Used and refurbished medical devices
  • Products that are exclusively manufactured or distributed as veterinary devices

Related Amazon help pages

Additional useful information

Examples of permitted medical device listings for sellers participating in the Professional Health Care program

These listings examples are prohibited for all other sellers.

Cancer tests:

  • PSA Prostate Specific Antigen
  • High-Sensitivity CRP Home Test Kit
  • Viaguard Accu-cervical Cancer Test

Cavity varnish:

  • Ascent F-Coat
  • Copal Varnish with Fluoride
  • Fluoridex
  • GC Fuji Varnish
  • Gluma Desensitizer PowerGel
  • MI Varnish
  • Nupro
  • Pulpdent Fluoride Varnish
  • Vanish Varnish

Continuous, Variable, and Bilevel Positive Airway Pressure (CPAP, VPAP, BiPAP) devices and their accessories:

  • BiPAP Plus
  • CPAP Masks
  • Devilbiss Intellipap
  • iDPAP Celestia CPAP Machine
  • Polaris EX CPAP
  • Respironics REMstar
  • RPM Bilevel CPAP System

Denture relining, repairing, or rebasing resin:

  • Coe Comfort
  • Coe-Soft
  • Coe-Soft LC

Electronic Muscle Stimulation (EMS) units:

  • Compex Sport Muscle STI EMS Kit
  • Drive Medical Digital EMS
  • Globus Sport
  • LG-200
  • LG-7500
  • Platinum TENS Unit and Muscle Stimulator
  • ProM-555
  • Russian Electronic Stimulation Kit
  • StimRX EMS

Defibrillators (not approved for over-the-counter use):

  • AED OnSite
  • FRx AED
  • HeartStart MRx
  • Lifeline AED
  • Medtronic Lifepak
  • MRL LifeQuest AED
  • Welch Allyn AED 20
  • Zoll AED Pro

Insulin pumps:

  • Animas Infusion Set
  • Contact Detach Infusion Set
  • GenStrip Blood Glucose Test Strips sold by Shasta Technologies LLC
  • Medtronic Minimed Paradigm Revel 523
  • One Touch Ping Glucose Management System

Mandibular advancement devices:

  • Airflow Pressure Transducer
  • Dymedix Reusable Airflow/Snore Sensor
  • Nose Breathe Mouthpiece for Heavy Snorer
  • Quiet Night Sleep Appliance
  • Removable Acrylic Herbst
  • Snore Guard
  • Snore Guard Advance
  • Snore Hook Discluder
  • Snore Sat Recorder
  • Snore-Aid Max

Oral cavity abrasive polishing agents:

  • Butler Calci-Flor Prophylaxis Paste
  • GC MI Paste
  • GC MI Paste Plus
  • Gelato Prophylaxis Paste
  • Enamel Pro
  • Mi Paste
  • MI Paste Plus
  • PREVENTECH Prophylaxis Paste with Fluoride
  • VOCO Paste

Penis enlargement devices:

  • Bathmate Penis Enlargement Pump
  • Bathmate Hydropump Hercules

Resin tooth bonding agents:

  • Ascent Bond Universal Adhesive System
  • Beautibond Multi
  • Beautibond Multi PR Plus
  • Cimara and Cimara Zircon
  • GC Fuji Bond LC
  • SilJet System

Chelation products:

  • Advanced Formula EDTA Oral Chelation
  • AlkaLife Alkaline Drops
  • Beyond Chelation Improved
  • Bio-Chelat Heavy Metal Chelator
  • Cardio Chelate
  • CardioRenew
  • CardioRestor
  • Detoxamin Oral
  • Detoxamin Suppositories
  • EBN Detoxifying Bentonite Clay
  • Kelatox Suppositories
  • Keto-Plex
  • Kids Chelat Heavy Metal Chelator
  • Kids Clear Detoxifying Clay Baths

Last update 05/24/2018

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