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FDA 510(k)

SPECT.E.N.S REPOSITIONABLE, SNAP-TYPE, TENS

K-Number: K894043 · 1989-08-11

ApplicantLabeltape Meditect, Inc.
Decision Date1989-08-11
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SPECT.E.N.S REPOSITIONABLE, SNAP-TYPE, TENS 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 1989-08-11 under 510(k) number K894043. 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 SPECT.E.N.S REPOSITIONABLE, SNAP-TYPE, TENS?

SPECT.E.N.S REPOSITIONABLE, SNAP-TYPE, TENS is a medical device that received FDA 510(k) clearance on 1989-08-11. The listed applicant is Labeltape Meditect, Inc.. The 510(k) number is K894043.

When did SPECT.E.N.S REPOSITIONABLE, SNAP-TYPE, TENS receive FDA 510(k) clearance?

SPECT.E.N.S REPOSITIONABLE, SNAP-TYPE, TENS received FDA 510(k) clearance on 1989-08-11, under 510(k) number K894043.

Who is the listed applicant for SPECT.E.N.S REPOSITIONABLE, SNAP-TYPE, TENS?

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 SPECT.E.N.S REPOSITIONABLE, SNAP-TYPE, TENS?

The FDA product code for SPECT.E.N.S REPOSITIONABLE, SNAP-TYPE, TENS is 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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