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DermaWave 5000 Combi Max System

by Dermawave, LLC

510(k) K040121

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 NumberK040121 Date17 Mar 2004ClearedStatusActive

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  • Withdrawn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
IMG
Device Class
Class II
Regulation
21 CFR Part 890.5860
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The DermaWave 5000 Combi Max System is a Stimulator, Ultrasound and Muscle, classified under FDA product code IMG. It is designed for applying therapeutic deep heat in physical medicine, combining ultrasound and muscle stimulation technologies to support non-invasive tissue treatment and rehabilitation.

This system is intended for use in clinical settings and has received FDA 510(k) clearance as substantially equivalent to predicate devices. It is supplied as a reusable medical device and is regulated under FDA regulation number 890.5860. The device operates within Class II classification and is authorized for distribution in the United States under registration numbers including 1528161 and others listed in the FDA database.

Questions

AI-generated answers, 1 Oct 2026

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

  • What is the DermaWave 5000 Combi Max System used for?

    The DermaWave 5000 Combi Max System is designed for applying therapeutic deep heat in physical medicine. It integrates ultrasound and muscle stimulation technologies to support non-invasive tissue treatment and rehabilitation, making it suitable for clinical settings where targeted deep tissue therapy is required.

  • Is the DermaWave 5000 Combi Max System reusable or single-use?

    The DermaWave 5000 Combi Max System is supplied as a reusable medical device. This classification allows for repeated use in clinical environments, provided proper maintenance and sterilization protocols are followed, ensuring safety and efficacy over multiple applications.

  • What regulatory approval does the DermaWave 5000 Combi Max System hold?

    The DermaWave 5000 Combi Max System has received FDA 510(k) clearance, confirming it is substantially equivalent to predicate devices under FDA product code IMG. This approval is specific to its intended use in applying therapeutic deep heat through ultrasound and muscle stimulation in physical medicine.

  • What are the key specifications or features of the DermaWave 5000 Combi Max System?

    The system operates under FDA regulation number 890.5860 and falls under Class II classification. It is authorized for distribution in the U.S. with multiple registration numbers, including 1528161. The device is categorized under the Physical Medicine specialty and is intended for clinical use in therapeutic settings.

  • How is the DermaWave 5000 Combi Max System supplied and maintained?

    As a reusable device, the DermaWave 5000 Combi Max System requires adherence to strict maintenance and sterilization protocols to ensure safety and functionality. Clinical facilities must follow manufacturer guidelines for cleaning, disinfection, and storage to prevent contamination and maintain performance for repeated use.