FDA 510(k)

FD TENS 2030, MODEL DFJ24T

K-Number: K052813 · 2006-01-25

Decision Date2006-01-25

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

FD TENS 2030, MODEL DFJ24T is the device name listed in this FDA 510(k) record. The listed applicant is Fuji Dynamics Limited. It received FDA 510(k) clearance on 2006-01-25 under 510(k) number K052813. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FD TENS 2030, MODEL DFJ24T?

FD TENS 2030, MODEL DFJ24T is a medical device that received FDA 510(k) clearance on 2006-01-25. The listed applicant is Fuji Dynamics Limited. The 510(k) number is K052813.

When did FD TENS 2030, MODEL DFJ24T receive FDA 510(k) clearance?

FD TENS 2030, MODEL DFJ24T received FDA 510(k) clearance on 2006-01-25, under 510(k) number K052813.

Who is the listed applicant for FD TENS 2030, MODEL DFJ24T?

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

What is the FDA product code for FD TENS 2030, MODEL DFJ24T?

The FDA product code for FD TENS 2030, MODEL DFJ24T is GZJ.

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Other records listing Fuji Dynamics Limited as applicant

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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.