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FDA 510(k)

STIMTECH TENS ELECTRODE

K-Number: K790345 · 1979-03-21

ApplicantStimulation Technology, Inc.
Decision Date1979-03-21
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STIMTECH TENS ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Stimulation Technology, Inc.. It received FDA 510(k) clearance on 1979-03-21 under 510(k) number K790345. 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 STIMTECH TENS ELECTRODE?

STIMTECH TENS ELECTRODE is a medical device that received FDA 510(k) clearance on 1979-03-21. The listed applicant is Stimulation Technology, Inc.. The 510(k) number is K790345.

When did STIMTECH TENS ELECTRODE receive FDA 510(k) clearance?

STIMTECH TENS ELECTRODE received FDA 510(k) clearance on 1979-03-21, under 510(k) number K790345.

Who is the listed applicant for STIMTECH TENS ELECTRODE?

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

What is the FDA product code for STIMTECH TENS ELECTRODE?

The FDA product code for STIMTECH TENS ELECTRODE 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 Stimulation Technology, 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.

K791048STIMTECH NEUROMUSCULAR STIMULATOR, C 600K781565ELECTRICAL NERVE STIMULATOR MODEL 6035K772224NERVE STIMULATOR, ELEC. TRANSCUTANEOUSK770447EPC INSTICKSK770448INS - T.E.N.S.

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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