Search Results
Found 1 results
510(k) Data Aggregation
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?
Applicant Name (Manufacturer) :
REMINGTON PRODUCTS COMPANY, L.L.C.
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.
Ask a Question
Page 1 of 1