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FDA 510(k)

TENS/FES/NMES ELECTRODES

K-Number: K983097 · 1999-09-17

ApplicantUni-Patch, Inc.
Decision Date1999-09-17
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENS/FES/NMES ELECTRODES 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 1999-09-17 under 510(k) number K983097. 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 TENS/FES/NMES ELECTRODES?

TENS/FES/NMES ELECTRODES is a medical device that received FDA 510(k) clearance on 1999-09-17. The listed applicant is Uni-Patch, Inc.. The 510(k) number is K983097.

When did TENS/FES/NMES ELECTRODES receive FDA 510(k) clearance?

TENS/FES/NMES ELECTRODES received FDA 510(k) clearance on 1999-09-17, under 510(k) number K983097.

Who is the listed applicant for TENS/FES/NMES ELECTRODES?

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 TENS/FES/NMES ELECTRODES?

The FDA product code for TENS/FES/NMES ELECTRODES is GXY.

Related Clinical Trials

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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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.

K962910SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECTRODE - MODIFYK962332TENS/FES/NMES ELECTRODESK961141EASY FLEX TENS/FES/MNS ELECTRODES 2 ROUND MODEL 8200/2X2 MODEL 8220K925466CONDUCT 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.

K262654Dexus Prosthetic System (MSL2, MSR2)Zhejiang Qiangnao Technology Co.,LtdK260578Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)Ambu A/SK261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc.K261522BioWave BioWrapsBiowave CorporationK253237Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)Elde Medikal Sanayi ve Ticaret Anonim SirketiK254183MR Conditional Cup ElectrodesTechnomed Europe

Official Source

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