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Miniphysionizer 2.0 And Electrodes

by Physion, Inc.

510(k) K022950

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK022950 Date18 Apr 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
EGJ
Device Class
Class II
Regulation
21 CFR Part 890.5525
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 Miniphysionizer 2.0 And Electrodes is a device, iontophoresis, other uses, classified as a physical medicine device. It is used for iontophoresis, which involves the introduction of ions into the body through the skin. The device is designed to deliver medication or other substances through the skin using a small electric current.

The Miniphysionizer 2.0 And Electrodes is supplied with electrodes and is intended for use in physical medicine applications. It is a class 2 device, regulated under 21 CFR 890.5525, and has been found to be substantially equivalent to other devices on the market. The device is manufactured by Physion, Inc. and has been authorized by the FDA under the 510(k) clearance process, with the clearance number K022950.

Other devices from Physion, Inc.

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 Miniphysionizer 2.0 used for?

    The Miniphysionizer 2.0 is used for iontophoresis, which involves introducing ions into the body through the skin, typically for physical medicine applications.

  • Is the Miniphysionizer 2.0 supplied with electrodes?

    Yes, the Miniphysionizer 2.0 is supplied with electrodes, which are necessary for its operation in delivering medication or other substances through the skin.

  • What regulatory pathway did the Miniphysionizer 2.0 follow?

    The Miniphysionizer 2.0 was authorized by the FDA under the 510(k) clearance process, with the clearance number K022950, indicating it was found substantially equivalent to other devices on the market.

  • What class of device is the Miniphysionizer 2.0?

    The Miniphysionizer 2.0 is classified as a Class 2 device, regulated under 21 CFR 890.5525, indicating a moderate level of risk and requiring special controls to ensure safety and effectiveness.