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FDA 510(k)

BEAR 2 Body

K-Number: K232242 · 2024-05-13

ApplicantForeo, Inc.
Decision Date2024-05-13
Product CodeNFO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BEAR 2 Body is the device name listed in this FDA 510(k) record. The listed applicant is Foreo, Inc.. It received FDA 510(k) clearance on 2024-05-13 under 510(k) number K232242. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BEAR 2 Body?

BEAR 2 Body is a medical device that received FDA 510(k) clearance on 2024-05-13. The listed applicant is Foreo, Inc.. The 510(k) number is K232242.

When did BEAR 2 Body receive FDA 510(k) clearance?

BEAR 2 Body received FDA 510(k) clearance on 2024-05-13, under 510(k) number K232242.

Who is the listed applicant for BEAR 2 Body?

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

What is the FDA product code for BEAR 2 Body?

The FDA product code for BEAR 2 Body is NFO.

Other records listing Foreo, Inc. 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.

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Related Devices (Code: NFO)

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

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