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TENS 7000, EMS 7500, and Twin Stim - Ems 7500

by Koalaty Products, Inc.

510(k) K080661

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

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

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK080661 Date24 Mar 2008ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IPF
Models / Variants
Ems 7500
Device Class
Class II
Regulation
21 CFR Part 890.5850
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.

These devices are transcutaneous electrical nerve stimulation (TENS) and electrical muscle stimulation (EMS) units, designed to deliver controlled electrical impulses for therapeutic purposes. The TENS 7000 provides five programmable modes with adjustable pulse rate, pulse width, and timer settings, while the EMS 7500 offers three modes with additional controls for contraction time, relaxation time, ramp time, and timer. The Twin Stim combines both TENS and EMS functionalities, allowing users to switch between modes via press buttons with identical parameter ranges to the standalone units.

The TENS 7000, EMS 7500, and Twin Stim are intended for clinical use in physical medicine settings and are classified under product code IPF. These devices are non-sterile, reusable, and not MRI-compatible. They are supplied as standalone units with adjustable settings tailored for therapeutic electrical stimulation. Authorized for commercial distribution in the United States under an FDA 510(k) clearance (K080661), they adhere to traditional review standards and are intended for use by trained professionals in physical therapy or rehabilitation environments.

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