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Rh-806/Gs Model Transq(R)2

by Iomed, Inc.

510(k) K932620

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 NumberK932620 Date26 Jul 1994ClearedStatusActive

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  • Withdrawn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, 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 RH-806/GS Model TransQ2 is a medical device classified under Iontophoresis for Other Uses, designed to deliver controlled iontophoresis therapy. Iontophoresis involves the use of a low electrical current to enhance the transdermal delivery of medicated solutions, typically for conditions such as hyperhidrosis or localized pain management.

This device is intended for use in clinical settings, supplied as a reusable Class II medical device under FDA 510(k) clearance (K932620) and regulatory classification EGJ. It operates under special controls as defined by the FDA and is intended for professional use by trained personnel. No specific sterility or single-use designation is stated in the provided data.

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