TENS PREP

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K893604 ↗

FDA Product Code

GYB

Device Class

Class II

Regulation

21 CFR Part 882.1275

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Opsite*wound (Flexigrid Application System)

  Class I

  FDA 510(k) K895408 Active Cleared 14 Dec 1989

• Allevyn Dressing Claims Change

  Class I

  FDA 510(k) K904412 Active Cleared 23 Oct 1990

• Solosite Dermal Wound Gel

  Unclassified

  FDA 510(k) K932263 Active Cleared 1 Oct 1993

• Glass Mercury Filled Thermometers

  Class II

  FDA 510(k) K893602 Active Cleared 8 Aug 1989

• Allevyn Adhesive

  Class I

  FDA 510(k) K945330 Active Cleared 9 Feb 1995

• Cavi-Care Conforming Foam Dressing

  Class I

  FDA 510(k) K943619 Active Cleared 19 Aug 1994

See all devices from Smith & Nephew United, Inc. →

• What is TENS PREP used for?

  TENS PREP is a conductive medium designed for use with transcutaneous electrical nerve stimulation (TENS) devices to facilitate the delivery of electrical impulses through the skin for neuromuscular stimulation, based on its classification under product code GYB and regulation number 882.1275.

• Is TENS PREP sterile when supplied?

  TENS PREP is supplied as a non-sterile device, as explicitly stated in the device data, meaning it does not undergo terminal sterilization and may require user-level sterilization or aseptic handling depending on clinical use.

• Can TENS PREP be reused or is it single-use?

  TENS PREP is supplied as a reusable or single-use conductive medium, indicating that its intended use allows for either multiple applications after proper cleaning or disposal after a single use, depending on user protocol and institutional policy.

• What regulatory pathway was used to clear TENS PREP?

  TENS PREP received FDA clearance through the traditional 510(k) pathway under submission K893604, demonstrating substantial equivalence to a legally marketed predicate device, as indicated by its decision code SESE and clearance date of November 21, 1989.

• What is the product classification and medical specialty associated with TENS PREP?

  TENS PREP is classified under product code GYB and regulation number 882.1275, and is associated with the neurology medical specialty, as reflected in its FDA classification and advisory committee designation.