BodyTom Elite
K-Number: K170238 · 2017-06-14
Decision Date2017-06-14
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
BodyTom Elite is a medical device manufactured by Neurologica Corporation, A Subsidiary of Samsung Electronics. It received FDA 510(k) clearance on 2017-06-14 under approval number K170238. 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 Elite?
BodyTom Elite is a medical device that received FDA 510(k) clearance on 2017-06-14. It is manufactured by Neurologica Corporation, A Subsidiary of Samsung Electronics. The 510(k) number is K170238.
When was BodyTom Elite approved by the FDA?
BodyTom Elite received FDA 510(k) clearance on 2017-06-14, under approval number K170238.
What company makes BodyTom Elite?
BodyTom Elite is manufactured by Neurologica Corporation, A Subsidiary of Samsung Electronics.
What is the FDA product code for BodyTom Elite?
The FDA product code for BodyTom Elite is JAK.
Other Devices by Neurologica Corporation, A Subsidiary of Samsung Electronics
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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.