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K Number
K001860
Device Name
PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA
Manufacturer
HOMEDICS, INC.
Date Cleared
2000-08-10

(52 days)

Product Code
IMC
Regulation Number
890.5110
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 890.5110 Paraffin bath.

(a)
Identification. A paraffin bath is a device intended for medical purposes that consists of a tub to be filled with liquid paraffin (wax) and maintained at an elevated temperature in which the patient's appendages (e.g., hands or fingers) are placed to relieve pain and stiffness.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.