BodyTom 64
K-Number: K242811 · 2025-03-14
Decision Date2025-03-14
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
BodyTom 64 is a medical device manufactured by Neurologica Corporation, A Subsidiary of Samsung. It received FDA 510(k) clearance on 2025-03-14 under approval number K242811. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BodyTom 64?
BodyTom 64 is a medical device that received FDA 510(k) clearance on 2025-03-14. It is manufactured by Neurologica Corporation, A Subsidiary of Samsung. The 510(k) number is K242811.
When was BodyTom 64 approved by the FDA?
BodyTom 64 received FDA 510(k) clearance on 2025-03-14, under approval number K242811.
What company makes BodyTom 64?
BodyTom 64 is manufactured by Neurologica Corporation, A Subsidiary of Samsung.
What is the FDA product code for BodyTom 64?
The FDA product code for BodyTom 64 is JAK.
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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.