FDA 510(k)

VibraPEP

K-Number: K163091 · 2017-02-21

Decision Date2017-02-21

Product CodeBWF

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

VibraPEP is the device name listed in this FDA 510(k) record. The listed applicant is Medica Holdings, LLC. It received FDA 510(k) clearance on 2017-02-21 under 510(k) number K163091. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VibraPEP?

VibraPEP is a medical device that received FDA 510(k) clearance on 2017-02-21. The listed applicant is Medica Holdings, LLC. The 510(k) number is K163091.

When did VibraPEP receive FDA 510(k) clearance?

VibraPEP received FDA 510(k) clearance on 2017-02-21, under 510(k) number K163091.

Who is the listed applicant for VibraPEP?

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

What is the FDA product code for VibraPEP?

The FDA product code for VibraPEP is BWF.

Other records listing Medica Holdings, LLC as applicant

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.

K172956Medicant Mucosal Atomizer K153441VibraPEP

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Official Source

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