CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000

• K Number: K011243
• Device Name: CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000
• Manufacturer: CHATTANOOGA GROUP, INC.
• Date Cleared: 2001-07-06 ( 74 days)
• Product Code: LSB
• Regulation Number: 890.5100

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

§ 890.5100 Immersion hydrobath.

(a)
Identification. An immersion hydrobath is a device intended for medical purposes that consists of water agitators and that may include a tub to be filled with water. The water temperature may be measured by a gauge. It is used in hydrotherapy to relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue.(b)
Classification. Class II (special controls). The device, when it is a hydromassage bath or a powered sitz bath, 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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