Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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● It is a portable, battery-powered, transcutaneous electrical nerve stimulator (TENS device) that is intended for symptomatic relief of chronic intractable pain. ● OTC TENS Device.
WELL-LIFE HEALTHCARE LTD.
WL-2407
Not in Commercial Distribution

  • 04719872264071 ()


  • Physical therapy transcutaneous electrical stimulation system, line-powered
The LED Lip Perfector (Model: ZC-05) is an Over-the-Counter (OTC) device intended to treat fine lines and wrinkles and increase in circulation within the perioral region.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
ZC-05
In Commercial Distribution

  • 00655729008426 ()


  • Cosmetic red-light phototherapy system, home-use
Bluetooth-enabled wireless OTC hearing aids, behind-the-ear design, 4 preset hearing modes, IP54 water resistant, with built-in rechargeable lithium battery, keychain remote, charging case and power adapter included.
Voxx Accessories Corp.
RSH082GM
In Commercial Distribution

  • 00044476158605 ()


  • Air-conduction hearing aid, receiver-in-canal
Lexie B2, Powered by Bose re-chargeable self-fitting hearing aid
HEARX GROUP (PTY) LTD
Lexie B2 Self-fitting OTC Hearing Aids Powered by Bose
In Commercial Distribution

  • 10850022464642 ()
  • 00850022464645 ()
In-Store

  • Air-conduction hearing aid, receiver-in-canal
Lexie B1 Hearing Aids, powered by Bose. Self-fit, app-controlled hearing aids
HEARX GROUP (PTY) LTD
Lexie B1 Self-fitting OTC Hearing Aids Powered by Bose
In Commercial Distribution

  • 00850022464577 ()
  • 10850022464574 ()
In-Store

  • Air-conduction hearing aid, receiver-in-canal
The Sunny Cup and Applicator is an OTC device indicated for use as a receptacle placed in the vagina to collect menstrual fluid and cellular debris that is extruded from the uterus via the cervix during menstruation.
Sunny
SUNAC011PEGI01
In Commercial Distribution

  • 00860009638617 ()


  • Menstrual cup, non-latex, reusable
Repair-it is an OTC denture repair kit for home use. The device consists of a material, such as a resin monomer system of powder and liquid glues, that is intended to be applied permanently to a denture to mend cracks or breaks.
Doc Brands, Inc.
1
In Commercial Distribution

  • 00372494101915 ()


  • Denture repair kit, home-use
● It is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. ● OTC TENS, Patch type.
WELL-LIFE HEALTHCARE LTD.
WL-2406
Not in Commercial Distribution

  • 04719872264064 ()


  • Physical therapy transcutaneous electrical stimulation system, line-powered
OTC Mini Patch, models: WL-2301A & WL-2301B Transcutaneous Electrical Nerve Stimulators and intended for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
WELL-LIFE HEALTHCARE LTD.
WL-2301
Not in Commercial Distribution

  • 04719872263012 ()


  • Physical therapy transcutaneous electrical stimulation system, line-powered
The Sure + is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence in women and to maintain urinary continence in women. The Sure + is intended for OTC use.
TENSCARE LIMITED
Sure+
In Commercial Distribution

  • 05033435134458 ()
K-SURE+USA

  • Perineal orifice incontinence-control electrical stimulation system
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