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K Number
K973590
Device Name
HEMORRELIEF DEVICE
Manufacturer
A. STEIN - REGULATORY AFFAIRS CONSULTING
Date Cleared
1998-02-05

(136 days)

Product Code
LKX
Regulation Number
N/A
Type
Traditional
Panel
GU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Hemorrelief device is intended to provide treatment for the relief of pain, itching, inflammation and bleeding of hemorrhoids by means of cryotherapy (controlled cold treatment).

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. The document is an FDA 510(k) clearance letter for a device called "Hemorrelief" and its corresponding Indications for Use statement. It confirms the device's substantial equivalence to a predicate device but does not include the specifics of a study or performance metrics. Therefore, I cannot generate the requested information based on the input.

N/A