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FDA 510(k)

LL TENS 160A, LL TENS 160B

K-Number: K152374 · 2016-01-13

Decision Date2016-01-13
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LL TENS 160A, LL TENS 160B is the device name listed in this FDA 510(k) record. The listed applicant is Fuji Dynamics , Ltd.. It received FDA 510(k) clearance on 2016-01-13 under 510(k) number K152374. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LL TENS 160A, LL TENS 160B?

LL TENS 160A, LL TENS 160B is a medical device that received FDA 510(k) clearance on 2016-01-13. The listed applicant is Fuji Dynamics , Ltd.. The 510(k) number is K152374.

When did LL TENS 160A, LL TENS 160B receive FDA 510(k) clearance?

LL TENS 160A, LL TENS 160B received FDA 510(k) clearance on 2016-01-13, under 510(k) number K152374.

Who is the listed applicant for LL TENS 160A, LL TENS 160B?

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

What is the FDA product code for LL TENS 160A, LL TENS 160B?

The FDA product code for LL TENS 160A, LL TENS 160B is NUH.

Other records listing Fuji Dynamics , Ltd. as applicant

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.

Related Devices (Code: NUH)

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.

Official Source

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