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Phoresor II, Model PM900

by Iomed, Inc. 2 variants

510(k) K974855

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)SN Traditional NumberK974855 Date27 Mar 1998DecidedStatusActive

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  • Withdrawn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
KTB
Device Class
Class II
Regulation
21 CFR Part 890.5525
Advisory Committee
Physical Medicine
FDA Decision
SN

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 Phoresor II, Model PM900 is a microprocessor-controlled iontophoresis device (product code KTB) designed to deliver ionized drugs transdermally via direct current. It facilitates the transport of soluble medications into body tissue, serving as an alternative to hypodermic injection to reduce needle-related discomfort and tissue trauma.

This battery-powered device operates using a 9V power source and allows user-adjustable parameters such as current strength and duration via pushbuttons. Supplied as a reusable Class II medical device under FDA 510(k) clearance (K974855), it is intended for use in physical medicine settings. No sterility or single-use specifications are indicated in the regulatory data.

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