FDA 510(k)

BodyTom Elite (NL4000)

Número K: K253450 · 2026-07-28

RequerenteNeuroLogica Corp., a Samsung Company

Data da decisão2026-07-28

Código do produtoJAK

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

BodyTom Elite (NL4000) is the device name listed in this FDA 510(k) record. The listed applicant is NeuroLogica Corp., a Samsung Company. It received FDA 510(k) clearance on 2026-07-28 under 510(k) number K253450. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BodyTom Elite (NL4000)?

BodyTom Elite (NL4000) is a medical device that received FDA 510(k) clearance on 2026-07-28. The listed applicant is NeuroLogica Corp., a Samsung Company. The 510(k) number is K253450.

When did BodyTom Elite (NL4000) receive FDA 510(k) clearance?

BodyTom Elite (NL4000) recebeu aprovação FDA 510(k) em 28 de julho de 2026, sob o número 510(k) K253450.

Who is the listed applicant for BodyTom Elite (NL4000)?

The FDA 510(k) record lists NeuroLogica Corp., a Samsung Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BodyTom Elite (NL4000)?

The FDA product code for BodyTom Elite (NL4000) is JAK.

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Dispositivos Relacionados (Código: JAK)

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