RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO

• K Number: K001079
• Device Name: RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO
• Manufacturer: ARJO, INC.
• Date Cleared: 2000-05-01 ( 27 days)
• Product Code: ILJ
• Regulation Number: 890.5100
• Type: Traditional
• Panel: PM
• Reference & Predicate Devices: N/A

Intended Use

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Device Description

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AI/ML 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.