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FDA 510(k)

SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECT.

K-Number: K900656 · 1990-03-01

ApplicantLabeltape Meditect, Inc.
Decision Date1990-03-01
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECT. is the device name listed in this FDA 510(k) record. The listed applicant is Labeltape Meditect, Inc.. It received FDA 510(k) clearance on 1990-03-01 under 510(k) number K900656. 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 SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECT.?

SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECT. is a medical device that received FDA 510(k) clearance on 1990-03-01. The listed applicant is Labeltape Meditect, Inc.. The 510(k) number is K900656.

When did SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECT. receive FDA 510(k) clearance?

SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECT. received FDA 510(k) clearance on 1990-03-01, under 510(k) number K900656.

Who is the listed applicant for SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECT.?

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

What is the FDA product code for SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECT.?

The FDA product code for SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECT. is GXY.

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Other records listing Labeltape Meditect, Inc. as applicant

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Related Devices (Code: GXY)

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Official Source

View on FDA Database →

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

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