FDA 510(k)

BodyTom 64 (NL4100); OmniTom Elite (NL5000)

N.º K: K261125 · 2026-09-22

SolicitanteSamsung HME America, Inc., dba NeuroLogica Corp.

Fecha de decisión2026-09-22

Código de productoJAK

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

BodyTom 64 (NL4100); OmniTom Elite (NL5000) is the device name listed in this FDA 510(k) record. The listed applicant is Samsung HME America, Inc., dba NeuroLogica Corp.. It received FDA 510(k) clearance on 2026-09-22 under 510(k) number K261125. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the BodyTom 64 (NL4100); OmniTom Elite (NL5000)?

BodyTom 64 (NL4100); OmniTom Elite (NL5000) is a medical device that received FDA 510(k) clearance on 2026-09-22. The listed applicant is Samsung HME America, Inc., dba NeuroLogica Corp.. The 510(k) number is K261125.

When did BodyTom 64 (NL4100); OmniTom Elite (NL5000) receive FDA 510(k) clearance?

BodyTom 64 (NL4100); OmniTom Elite (NL5000) received FDA 510(k) clearance on 2026-09-22, under 510(k) number K261125.

Who is the listed applicant for BodyTom 64 (NL4100); OmniTom Elite (NL5000)?

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

What is the FDA product code for BodyTom 64 (NL4100); OmniTom Elite (NL5000)?

The FDA product code for BodyTom 64 (NL4100); OmniTom Elite (NL5000) is JAK.

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Fuente oficial

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