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FDA 510(k)

IMPAX, MALE IMPOTENCE AID

K-Number: K861468 · 1986-06-18

ApplicantLehigh Group
Decision Date1986-06-18
Product CodeLKY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

IMPAX, MALE IMPOTENCE AID is the device name listed in this FDA 510(k) record. The listed applicant is Lehigh Group. It received FDA 510(k) clearance on 1986-06-18 under 510(k) number K861468. The device is classified under product code LKY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPAX, MALE IMPOTENCE AID?

IMPAX, MALE IMPOTENCE AID is a medical device that received FDA 510(k) clearance on 1986-06-18. The listed applicant is Lehigh Group. The 510(k) number is K861468.

When did IMPAX, MALE IMPOTENCE AID receive FDA 510(k) clearance?

IMPAX, MALE IMPOTENCE AID received FDA 510(k) clearance on 1986-06-18, under 510(k) number K861468.

Who is the listed applicant for IMPAX, MALE IMPOTENCE AID?

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

What is the FDA product code for IMPAX, MALE IMPOTENCE AID?

The FDA product code for IMPAX, MALE IMPOTENCE AID is LKY.

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Related Devices (Code: LKY)

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.

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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.

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