Search Results
Found 1 results
510(k) Data Aggregation
K Number
K993906Device Name
NANMA NON-ADJUSTABLE CONSTRICTION RINGManufacturer
Date Cleared
2000-01-31
(75 days)
Product Code
Regulation Number
876.5020Type
TraditionalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Nanma non-adjustable constriction rings are external penile rigidity devices used for the treatment or management of erectile dysfunction/impotence.
Device Description
Nanma non-adjustable constriction ring
AI/ML Overview
This document is a 510(k) clearance letter from the FDA for the 'NANMA Non-adjustable Constriction Ring'. It does not contain information about the acceptance criteria, study details, or device performance metrics as requested in the prompt. The letter confirms substantial equivalence to a predicate device and permits marketing, but it does not include clinical trial data, sample sizes, expert qualifications, or ground truth establishment.
Ask a Question
Ask a specific question about this device
Page 1 of 1