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FDA 510(k)

TENS PREP

K-Number: K893604 · 1989-11-21

ApplicantSmith & Nephew United, Inc.
Decision Date1989-11-21
Product CodeGYB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENS PREP is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew United, Inc.. It received FDA 510(k) clearance on 1989-11-21 under 510(k) number K893604. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENS PREP?

TENS PREP is a medical device that received FDA 510(k) clearance on 1989-11-21. The listed applicant is Smith & Nephew United, Inc.. The 510(k) number is K893604.

When did TENS PREP receive FDA 510(k) clearance?

TENS PREP received FDA 510(k) clearance on 1989-11-21, under 510(k) number K893604.

Who is the listed applicant for TENS PREP?

The FDA 510(k) record lists Smith & Nephew United, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TENS PREP?

The FDA product code for TENS PREP is GYB.

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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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