FDA 510(k)

ELECTRICAL NERVE STIMULATION(TENS) ELECTRODES

K-Number: K852267 · 1985-06-18

Decision Date1985-06-18

Product CodeGXY

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

ELECTRICAL NERVE STIMULATION(TENS) ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Axelgaard Mfg. Co., Ltd.. It received FDA 510(k) clearance on 1985-06-18 under 510(k) number K852267. 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 ELECTRICAL NERVE STIMULATION(TENS) ELECTRODES?

ELECTRICAL NERVE STIMULATION(TENS) ELECTRODES is a medical device that received FDA 510(k) clearance on 1985-06-18. The listed applicant is Axelgaard Mfg. Co., Ltd.. The 510(k) number is K852267.

When did ELECTRICAL NERVE STIMULATION(TENS) ELECTRODES receive FDA 510(k) clearance?

ELECTRICAL NERVE STIMULATION(TENS) ELECTRODES received FDA 510(k) clearance on 1985-06-18, under 510(k) number K852267.

Who is the listed applicant for ELECTRICAL NERVE STIMULATION(TENS) ELECTRODES?

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

What is the FDA product code for ELECTRICAL NERVE STIMULATION(TENS) ELECTRODES?

The FDA product code for ELECTRICAL NERVE STIMULATION(TENS) ELECTRODES is GXY.

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Other records listing Axelgaard Mfg. Co., Ltd. as applicant

K130987VALUTRODE NEUROSTIMLATION ELECTRODES K080580COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D K013532ULTRASTIM KIT K000947ULTRASTIM ELECTRODE, MODEL US4040 K000206PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200 K983741EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.