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FDA 510(k)

T.E.N.S. ELECTRODE NON-STERILE

K-Number: K881444 · 1988-06-10

ApplicantTens Accessories, Inc.
Decision Date1988-06-10
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

T.E.N.S. ELECTRODE NON-STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Tens Accessories, Inc.. It received FDA 510(k) clearance on 1988-06-10 under 510(k) number K881444. 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 T.E.N.S. ELECTRODE NON-STERILE?

T.E.N.S. ELECTRODE NON-STERILE is a medical device that received FDA 510(k) clearance on 1988-06-10. The listed applicant is Tens Accessories, Inc.. The 510(k) number is K881444.

When did T.E.N.S. ELECTRODE NON-STERILE receive FDA 510(k) clearance?

T.E.N.S. ELECTRODE NON-STERILE received FDA 510(k) clearance on 1988-06-10, under 510(k) number K881444.

Who is the listed applicant for T.E.N.S. ELECTRODE NON-STERILE?

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

What is the FDA product code for T.E.N.S. ELECTRODE NON-STERILE?

The FDA product code for T.E.N.S. ELECTRODE NON-STERILE is GXY.

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Related Devices (Code: GXY)

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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.

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