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Found 7 results
510(k) Data Aggregation
K Number
K093100Device Name
REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA)
Manufacturer
SHENZHEN COMFORT TECHNOLOGY CO., LTD.
Date Cleared
2009-11-24
(54 days)
Product Code
IMC
Regulation Number
890.5110Why did this record match?
Product Code :
IMC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Revlon RVSP3501 (Type SPB3752EA) Spa MoistureStay Paraffin Bath is:
- Useful in symptomatic relief of pain caused by arthritis, bursitis, and chronic joint inflammation.
- Relaxes muscles, relieves stiffness and muscle spasm
- Stimulates circulation and for other conditions where heat is indicated.
Device Description
The Revlon RVSP3501 (Type SPB3752EA) Spa MoistureStay Paraffin Bath is an 80 Watt paraffin bath unit, with a thermostat that varies the heat from High to Keep Warm. There are two LEDs, a red LED for the heater, and a green LED to indicate the power. The unit is provided with 3lbs of paraffin wax, a plastic mat when dipping the hands or feet, glove liners, and a pair of mitts.
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K Number
K022626Device Name
MOISTURESTAY (REVLON)
Manufacturer
RAYMOND INDUSTRIAL, LTD.
Date Cleared
2002-10-29
(83 days)
Product Code
IMC
Regulation Number
890.5110Why did this record match?
Product Code :
IMC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Useful in symptomatic relief of pain caused by arthritis, bursitis, and chronic joint inflammation.
Relaxes muscles, relieves stiffness and muscle spasm.
Stimulates circulation and for other conditions where heat is indicated.
Device Description
Luxury Paraffin Bath
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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?
Product Code :
IMC
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.
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K Number
K013328Device Name
REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600
Manufacturer
REMINGTON PRODUCTS COMPANY, L.L.C.
Date Cleared
2001-12-03
(59 days)
Product Code
IMC
Regulation Number
890.5110Why did this record match?
Product Code :
IMC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Useful for symptomatic relief of pain caused by arthritis, bursitis, and chronic joint inflammation.
- Relaxes muscles, relieves stiffness and muscle spasm.
- Stimulates circulation and for other conditions where heat is indicated.
Device Description
The product covered by this 510(k) summary is a heated paraffin wax spa intended for home use. This product consists of a plastic enclosure, aluminum bucket and an internal heating assembly. The paraffin wax temperature is controlled by a variable electronic heat control with timing circuit. Temperature settings (low, medium, and high) and timing controls are displayed on a liquid crystal display. The product consumes 200 watts when plugged into a standard household electrical outlet supply of 120 Vac, 60 Hertz. The product comes in two different sizes.
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K Number
K001860Device Name
PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA
Manufacturer
HOMEDICS, INC.
Date Cleared
2000-08-10
(52 days)
Product Code
IMC
Regulation Number
890.5110Why did this record match?
Product Code :
IMC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K991427Device Name
PARAMED PARAFFIN WARMER
Manufacturer
DIVI INTL. CO.
Date Cleared
1999-08-13
(112 days)
Product Code
IMC
Regulation Number
890.5110Why did this record match?
Product Code :
IMC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use in temporary symptomatic relief of minor pain due to medically diagnosed arthritis and bursitis.
Relaxes muscles, aids in the relief of stiff muscles, muscle spasms; helps to stimulate circulation.
Device Description
Paramed Paraffin Warmer
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K Number
K980718Device Name
PARA-CARE
Manufacturer
CHATTANOOGA GROUP, INC.
Date Cleared
1998-03-27
(31 days)
Product Code
IMC
Regulation Number
890.5110Why did this record match?
Product Code :
IMC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Useful in symptomatic relief of pain caused by medically diagnosed arthritis, bursitis, and chronic joint inflammation.
Relaxes muscles, relieves stiffness and muscle spasm.
Stimulates circulation and for other conditions where heat is indicated.
Device Description
Not Found
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