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K Number
K963824
Device Name
LI'S ITCH STOPPER
Manufacturer
HONTECH FOUNDATION FOR MEDICAL TECHNOLOGY
Date Cleared
1996-12-12

(80 days)

Product Code
IRT
Regulation Number
890.5740
Type
Traditional
Panel
Physical Medicine
Reference & Predicate Devices
N/A
Predicate For
K160943,K964397
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 890.5740 Powered heating pad.

(a)
Identification. A powered heating pad is an electrical device intended for medical purposes that provides dry heat therapy for body surfaces. It is capable of maintaining an elevated temperature during use.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E part 807 of this chapter subject to § 890.9.