UROSURGE ACUTRAINER

• K Number: K962770
• Device Name: UROSURGE ACUTRAINER
• Manufacturer: PRINCETON REGULATORY ASSOC.
• Date Cleared: 1996-08-01 ( 16 days)
• Product Code: KPN
• Regulation Number: 876.2040

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

§ 876.2040 Enuresis alarm.

(a)
Identification. An enuresis alarm is a device intended for use in treatment of bedwetting. Through an electrical trigger mechanism, the device sounds an alarm when a small quantity of urine is detected on a sensing pad. This generic type of device includes conditioned response enuresis alarms.(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 § 876.9.

Summary

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