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FDA 510(k)

SENTRY FLEXIBLE TENS

K-Number: K853552 · 1985-09-26

ApplicantSentry Medical Products, Inc.
Decision Date1985-09-26
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SENTRY FLEXIBLE TENS is the device name listed in this FDA 510(k) record. The listed applicant is Sentry Medical Products, Inc.. It received FDA 510(k) clearance on 1985-09-26 under 510(k) number K853552. 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 SENTRY FLEXIBLE TENS?

SENTRY FLEXIBLE TENS is a medical device that received FDA 510(k) clearance on 1985-09-26. The listed applicant is Sentry Medical Products, Inc.. The 510(k) number is K853552.

When did SENTRY FLEXIBLE TENS receive FDA 510(k) clearance?

SENTRY FLEXIBLE TENS received FDA 510(k) clearance on 1985-09-26, under 510(k) number K853552.

Who is the listed applicant for SENTRY FLEXIBLE TENS?

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

What is the FDA product code for SENTRY FLEXIBLE TENS?

The FDA product code for SENTRY FLEXIBLE TENS is GXY.

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Other records listing Sentry Medical Products, Inc. as applicant

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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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