Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Prenuvo Body Composition

K-Number: K242825 · 2025-01-17

ApplicantPrenuvo
Decision Date2025-01-17
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Prenuvo Body Composition is the device name listed in this FDA 510(k) record. The listed applicant is Prenuvo. It received FDA 510(k) clearance on 2025-01-17 under 510(k) number K242825. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Prenuvo Body Composition?

Prenuvo Body Composition is a medical device that received FDA 510(k) clearance on 2025-01-17. The listed applicant is Prenuvo. The 510(k) number is K242825.

When did Prenuvo Body Composition receive FDA 510(k) clearance?

Prenuvo Body Composition received FDA 510(k) clearance on 2025-01-17, under 510(k) number K242825.

Who is the listed applicant for Prenuvo Body Composition?

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

What is the FDA product code for Prenuvo Body Composition?

The FDA product code for Prenuvo Body Composition is LNH.

Related Devices (Code: LNH)

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.

K253808AIR Recon DLGE Medical SystemsK261331I-Genius (100019400)Esaote, S.p.A.K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AGK260113uMR AstraShanghai United Imaging Healthcare Co., Ltd.K253862APERTO Lucent MRI SystemFujifilm CorporationK260746S-scan Open (100001800)Esaote, S.p.A.

Official Source

View on FDA Database →

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

↑