PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA

• 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

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 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.

Summary

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