The Leadaway

by Therapy Equipment, Inc.

510(k) K992372

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K992372↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK992372	Date13 Oct 1999Cleared	StatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K992372
FDA Product Code: IKD

Device Class: Class II
Regulation: 21 CFR Part 890.1175
Advisory Committee: Physical Medicine
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Leadaway is a lead wire designed for use with electrotherapy devices, classified under the FDA product code IKD as a Physical Medicine device. It facilitates the transmission of electrical signals in therapeutic applications, ensuring proper connectivity between the device and the patient.

This device is supplied as a reusable component, intended for use in clinical settings where electrotherapy is administered. It is not sterile and requires proper cleaning and maintenance between uses. The Leadaway holds an FDA 510(k) clearance (K992372) under the Traditional pathway, authorized for distribution by Therapy Equipment, Inc.