Search Results
Found 3 results
510(k) Data Aggregation
K Number
K013707Device Name
SOFTIQUE, MODEL GI 11001
Manufacturer
GLOBAL TV CONCEPTS, LTD.
Date Cleared
2002-02-01
(85 days)
Product Code
IMC
Regulation Number
890.5110Why did this record match?
Applicant Name (Manufacturer) :
GLOBAL TV CONCEPTS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Softique™ Paraffin Bath is an over-the-counter device intended for the following uses:
1. Useful in symptomatic relief of pain caused by arthritis, bursitis, and chronic joint inflammation
2. Relaxes muscles, relieves stiffness and muscle spasm
3. Stimulates circulation and for other conditions where heat is indicated
Device Description
The Softique™ Paraffin Bath is a full-size paraffin bath with a paraffin wax capacity of five pounds (with a recommended use of three to four pounds of paratin wax), a melting time for the paraffin wax of approximately five hours, and a temperature range for the paraffin wax of 123-130°F. The unit utilizes two heaters with a total of 90 W in order to melt and maintain the temperature of the melted paraffin wax. The unit has an operation voltage of 120 V, 60 Hz. The Softique™ Paraffin Bath is supplied with a power cord, a plastic lid, three pounds of pure, hypo-allergenic paraffin wax, and 60 plastic liners.
Ask a Question
K Number
K973174Device Name
SONIQUE HAIR REMOVER
Manufacturer
GLOBAL TV CONCEPTS, LTD.
Date Cleared
1997-10-30
(66 days)
Product Code
KCX
Regulation Number
878.5360Why did this record match?
Applicant Name (Manufacturer) :
GLOBAL TV CONCEPTS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the removal of hair
Device Description
The device works by emitting from the tweezer tips radio frequency energy that is transmitted down an individual hair grasped by the tweezers to the root and papilla of the hair. The tweezers may also be used to slide the hair out after treatment. The radio frequency energy destroys the papilla, with the result that the hair does not grow back. More than one treatment may be necessary.
Ask a Question
K Number
K973179Device Name
FEMINIQUE SONIC HAIR REMOVER
Manufacturer
GLOBAL TV CONCEPTS, LTD.
Date Cleared
1997-10-30
(66 days)
Product Code
KCX
Regulation Number
878.5360Why did this record match?
Applicant Name (Manufacturer) :
GLOBAL TV CONCEPTS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the removal of hair
Device Description
The device works by emitting from the tweezer tips radio frequency energy that is transmitted down an individual hair grasped by the tweezers to the root and papilla of the hair. The tweezers may also be used to slide the hair out after treatment. The radio frequency energy destroys the papilla, with the result that the hair does not grow back. More than one treatment may be necessary.
Ask a Question
Page 1 of 1