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510(k) Data Aggregation
K Number
K162392Device Name
Avazzia
Manufacturer
AVAZZIA, INC.
Date Cleared
2017-05-12
(259 days)
Product Code
NUH
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
AVAZZIA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Transcutaneous Electrical Nerve Stimulation (TENS) for the temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
Device Description
Avazzia OTC TENS electronic pulse massage devices are electrically powered device intended for overthe-counter use and used to apply a microcurrent electrical pulses to electrodes on a user's skin to relieve pain. They are easy-to-use, handheld, AA battery-operated portable devices for use in the home or clinic. The candidate devices have pre-set modes. The devices are portable, battery operated microcurrent electrical stimulation device that applies charge and power to the tissue through electrodes where maximum power delivered to the load is controlled and limited, and an automatic shut off is implemented. The user can apply the built-in onboard electrodes or place self-adhesive conductive electrodes where indicated and apply stimulation for a period of time. The user controls the output by selecting the mode and power setting.
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K Number
K123099Device Name
Best-AV2 Pro-Sport(tm)
Manufacturer
AVAZZIA, INC.
Date Cleared
2014-05-23
(598 days)
Product Code
GZJ
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
AVAZZIA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Pro-Sport™ is indicated for:
- . symptomatic relief and management of chronic, intractable pain
- adjunctive treatment in the management of post-surgical and post-traumatic pain .
Device Description
The candidate Pro-Sport Avazzia device is a micro-current transcutaneous electro-stimulation device. It is an easy-to-use, handheld, AA battery-operated portable device for use in the home or clinic.
The device is a portable, battery operated microcurrent electrical stimulation device that applies charge and power to the tissue through electrodes where maximum power delivered to the load is controlled and limited, and an automatic shut off is implemented.
The user can passively place the electrodes where indicated and apply stimulation for a period of time.
The user controls the output by selecting the preset mode and power setting. The device's controls and visual indicators are located on the upper side of the case and on the upper cover.
The Pro-Sport™ device incorporates a more sophisticated digital liquid crystal display user interface to help the user select the mode and see parameters like the power level, time, and other information and has one mode that allows practitioners to set up their own therapy signals.
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K Number
K062641Device Name
BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1
Manufacturer
AVAZZIA, INC.
Date Cleared
2007-04-30
(236 days)
Product Code
GZJ
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
AVAZZIA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and posttraumatic pain.
Device Description
The four Avazzia Biofeedback Electro-Stimulation Technology (BEST) devices are biofeedback, micro-current transcutaneous electro-stimulation devices for symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and post-traumatic pain. They are easy-to-use, handheld, AA battery-operated portable devices for use in the home or clinic.
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