TRIVARION BUFFERED IONTOPHORESIS ELECTRODE SYSTEM— 510(k) K061522

Name: FDA 510(k) clearance K061522
Creator: U.S. Food and Drug Administration
Published: 2006-08-01

Substantially Equivalent

Activatek, Inc.

FDA 510(k) clearance K061522 for TRIVARION BUFFERED IONTOPHORESIS ELECTRODE SYSTEM, Substantially Equivalent on 2006-08-01. Applicant: Activatek, Inc.. Device class: 2.

Clearance details

Applicant: Activatek, Inc.
Product code: Code EGJ
Device class: Class 2
Regulation: 21 CFR 890.5525
Advisory panel: Physical Medicine
Date received: 2006-06-02
Decision date: 2006-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EGJ

view all

K242041 — STOPWET iontophoresis apparatus (SW01)2025-04-01
K241267 — Hidroxa SE302024-10-17
K232020 — Iontophoresis Electrodes2023-10-16
K192749 — Dermadry2020-02-10
K191436 — Saalio2019-10-18

More clearances from Activatek, Inc.

view all

K132832 — ACTIVAPATCH ET IONTOPHORESIS PATCH2014-02-13
K091326 — ACTIVAPATCH2009-05-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.