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FDA 510(k)

EASY FLEX TENS/FES/MNS ELECTRODES 2 ROUND MODEL 8200/2X2 MODEL 8220

K-Number: K961141 · 1996-05-10

ApplicantUni-Patch, Inc.
Decision Date1996-05-10
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EASY FLEX TENS/FES/MNS ELECTRODES 2 ROUND MODEL 8200/2X2 MODEL 8220 is the device name listed in this FDA 510(k) record. The listed applicant is Uni-Patch, Inc.. It received FDA 510(k) clearance on 1996-05-10 under 510(k) number K961141. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EASY FLEX TENS/FES/MNS ELECTRODES 2 ROUND MODEL 8200/2X2 MODEL 8220?

EASY FLEX TENS/FES/MNS ELECTRODES 2 ROUND MODEL 8200/2X2 MODEL 8220 is a medical device that received FDA 510(k) clearance on 1996-05-10. The listed applicant is Uni-Patch, Inc.. The 510(k) number is K961141.

When did EASY FLEX TENS/FES/MNS ELECTRODES 2 ROUND MODEL 8200/2X2 MODEL 8220 receive FDA 510(k) clearance?

EASY FLEX TENS/FES/MNS ELECTRODES 2 ROUND MODEL 8200/2X2 MODEL 8220 received FDA 510(k) clearance on 1996-05-10, under 510(k) number K961141.

Who is the listed applicant for EASY FLEX TENS/FES/MNS ELECTRODES 2 ROUND MODEL 8200/2X2 MODEL 8220?

The FDA 510(k) record lists Uni-Patch, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EASY FLEX TENS/FES/MNS ELECTRODES 2 ROUND MODEL 8200/2X2 MODEL 8220?

The FDA product code for EASY FLEX TENS/FES/MNS ELECTRODES 2 ROUND MODEL 8200/2X2 MODEL 8220 is GXY.

Related Clinical Trials

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Other records listing Uni-Patch, Inc. 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.

K983097TENS/FES/NMES ELECTRODESK962910SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECTRODE - MODIFYK962332TENS/FES/NMES ELECTRODESK925466CONDUCT ALOE GEL, #UP239-8FL. OZ/#UP245 G-1 GALLONK871222TANTONE MULTI-DAY #633 TENS ELECTRODE

Related Devices (Code: GXY)

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.

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Official Source

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