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510(k) Data Aggregation
K Number
K030437Device Name
RELAXOR PERFECT TOUCH AIR MASSAGING SYSTEM
Manufacturer
SALTON, INC.
Date Cleared
2003-04-10
(59 days)
Product Code
IRP
Regulation Number
890.5650Why did this record match?
Applicant Name (Manufacturer) :
SALTON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Perfect Touch™ Air Massaging System is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Perfect Touch™ simulates kneading and stroking of tissues by using an inflatable garment.
Device Description
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K Number
K011935Device Name
REJUVENIQUE MODEL #RJV10
Manufacturer
SALTON, INC.
Date Cleared
2001-08-08
(48 days)
Product Code
NFO
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
SALTON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rejuvenique System is indicated for cosmetic use.
Device Description
The Rejuvenique facial toning system consists of three connected components a face mask, connecting cable and control unit. The mask is a PBC mask that is shaped to fit over the user's face. It is held on the user's face by an adjustable headband. It contains 26 fixed-position, gold plated, brass electrodes. The connecting cable is an 8-conducter cable in a PVC jacket. It connects the face mask to the control unit by modular, phone jack-style plugs on each end. The Control Unit contains the power-source ( a nine-volt battery), and the microprocessor control. When the Rejuvenique® system is activated, it provides a stimulus to the first pair of electrodes for 20 seconds, and then the microprocessor automatically switches to the next pair of electrodes in the sequence. The Facial Point Location Display indicates which pair of electrodes are currently activated (1-12). A full cycle through the 12 pairs of electrodes requires approximately 4 minutes. Unless stopped by the user the product will go through four complete cycles (approximately 20 minutes), and then automatically shuts off.
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