Product Code: KTB FDA class 2 21 CFR 890.5525

Device, Iontophoresis, Specific Uses

Physical Medicine

This device is an iontophoresis device for specific uses, which employs a low-level electrical current to drive ionized medications through the skin into underlying tissues for targeted local drug delivery, used in physical medicine for conditions such as inflammation, hyperhidrosis, or pain management. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KTB, regulated under 21 CFR 890.5525 within the Physical Medicine specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: KTB
Device Class: FDA class 2
Regulation Number: 890.5525
Medical Specialty: Physical Medicine
Review Panel: PM
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 16 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K180627	Macroduct Advanced Model 3710	Jul 27, 2018	Substantially Equivalent	Elitechgroup, Inc.
K033192	RH-950	Dec 22, 2003	Substantially Equivalent	Iomed, Inc.
K031551	NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D)	Aug 20, 2003	Substantially Equivalent	Vyteris, Inc.
K031115	RH-900	Jul 10, 2003	Substantially Equivalent	Iomed, Inc.
K010031	NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM	Mar 20, 2001	Substantially Equivalent	Wescor, Inc.
K001522	TRANSQ3	Oct 18, 2000	Substantially Equivalent	Iomed, Inc.
K001410	PHORESOR MODEL PM2000	Aug 01, 2000	Substantially Equivalent	Iomed, Inc.
K992874	Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM	Nov 18, 1999	Substantially Equivalent	Wr Medical Electronics Co.
K974855	PHORESOR II, MODEL PM900	Mar 27, 1998	Substantially Equivalent for Some Indications	Iomed, Inc.
K954126	TRANSQ ELECTRODE PHORESOR II	Jan 19, 1996	Substantially Equivalent for Some Indications	Iomed, Inc.
K895775	CF INDICATOR MODEL 9800 SWEAT TEST SYSTEM	Apr 23, 1990	Substantially Equivalent	Medtronic Vascular
K853973	WESCOR MODEL 3700 WEBSTER SWEAT INDUCER	Oct 16, 1985	Substantially Equivalent	Wescor, Inc.
K840472	SYS MACRODUCT SWEAT COLLECTION SYS 3600	Mar 19, 1984	Substantially Equivalent	Wescor, Inc.
K832059	IONOPHORELIC SWEAT STIM. CHLORIDE-	Aug 24, 1983	Substantially Equivalent	Medtronic Vascular
K790205	ELECTROAPPLICATOR MODEL C-1	Mar 19, 1979	Substantially Equivalent	Mcg, Inc.
K781700	IONOTPHORETIC APPLICATOR	Nov 03, 1978	Substantially Equivalent	Mcghan Medical Corp.