FDA 510(k)

ActiPatch

K-Number: K192234 · 2020-01-31

Decision Date2020-01-31

Product CodePQY

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

ActiPatch is the device name listed in this FDA 510(k) record. The listed applicant is Bioelectronics Corporation. It received FDA 510(k) clearance on 2020-01-31 under 510(k) number K192234. The device is classified under product code PQY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ActiPatch?

ActiPatch is a medical device that received FDA 510(k) clearance on 2020-01-31. The listed applicant is Bioelectronics Corporation. The 510(k) number is K192234.

When did ActiPatch receive FDA 510(k) clearance?

ActiPatch received FDA 510(k) clearance on 2020-01-31, under 510(k) number K192234.

Who is the listed applicant for ActiPatch?

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

What is the FDA product code for ActiPatch?

The FDA product code for ActiPatch is PQY.

Other records listing Bioelectronics Corporation 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.

K190251RecoveryRx K152432ActiPatch(R)

Related Devices (Code: PQY)

K152432ActiPatch(R)Bioelectronics Corporation

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.