Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VIBERECT PENILE VIBRATORY STIMULATION DEVICE

K-Number: K110566 · 2011-06-24

Decision Date2011-06-24
Product CodeKXQ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

VIBERECT PENILE VIBRATORY STIMULATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Reflexonic, LLC. It received FDA 510(k) clearance on 2011-06-24 under 510(k) number K110566. The device is classified under product code KXQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIBERECT PENILE VIBRATORY STIMULATION DEVICE?

VIBERECT PENILE VIBRATORY STIMULATION DEVICE is a medical device that received FDA 510(k) clearance on 2011-06-24. The listed applicant is Reflexonic, LLC. The 510(k) number is K110566.

When did VIBERECT PENILE VIBRATORY STIMULATION DEVICE receive FDA 510(k) clearance?

VIBERECT PENILE VIBRATORY STIMULATION DEVICE received FDA 510(k) clearance on 2011-06-24, under 510(k) number K110566.

Who is the listed applicant for VIBERECT PENILE VIBRATORY STIMULATION DEVICE?

The FDA 510(k) record lists Reflexonic, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VIBERECT PENILE VIBRATORY STIMULATION DEVICE?

The FDA product code for VIBERECT PENILE VIBRATORY STIMULATION DEVICE is KXQ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: KXQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑