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FDA 510(k)

Portare System (FA-001)

K-Number: K243639 · 2025-06-05

ApplicantGrumpy Innovation, Inc.
Decision Date2025-06-05
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Portare System (FA-001) is the device name listed in this FDA 510(k) record. The listed applicant is Grumpy Innovation, Inc.. It received FDA 510(k) clearance on 2025-06-05 under 510(k) number K243639. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Portare System (FA-001)?

Portare System (FA-001) is a medical device that received FDA 510(k) clearance on 2025-06-05. The listed applicant is Grumpy Innovation, Inc.. The 510(k) number is K243639.

When did Portare System (FA-001) receive FDA 510(k) clearance?

Portare System (FA-001) received FDA 510(k) clearance on 2025-06-05, under 510(k) number K243639.

Who is the listed applicant for Portare System (FA-001)?

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

What is the FDA product code for Portare System (FA-001)?

The FDA product code for Portare System (FA-001) is EOB.

Related Devices (Code: EOB)

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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