Product Code: ILX FDA class 2 21 CFR 890.5290

Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat

Physical Medicine

A Shortwave Diathermy Device for uses other than applying therapeutic deep heat is a radiofrequency electromagnetic device used in Physical Medicine for clinical applications such as stimulation or diagnostic purposes, distinguished from therapeutic deep-heating diathermy by its intended use. It is classified as FDA Class 2, representing moderate risk, meaning it requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device before marketing. The product code is ILX, regulated under 21 CFR 890.5290, within the Physical Medicine medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: ILX
Device Class: FDA class 2
Regulation Number: 890.5290
Medical Specialty: Physical Medicine
Review Panel: PM
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 15 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K241395	Active System; Avenue8	Dec 18, 2024	Substantially Equivalent	Caerus Corporation
K202337	Pulsed electromagnetic field wrap	Dec 15, 2020	Substantially Equivalent	Hi-Dow International, Inc.
K190251	RecoveryRx	Jun 28, 2019	Substantially Equivalent	Bioelectronics Corporation
K131979	PROVANT THERAPY SYSTEM	Dec 13, 2013	Substantially Equivalent	Regenesis Biomedical, Inc.
K121702	ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE	May 06, 2013	Substantially Equivalent	Orthocor Medical
K121338	ZEOBI	Jul 27, 2012	Substantially Equivalent	Ivivi Health Science, LLC
K091791	PROVANT SYSTEM, MODEL 4201	Apr 07, 2010	Substantially Equivalent	Regenesis Biomedical, Inc.
K092044	ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE	Dec 18, 2009	Substantially Equivalent	Orthocor Medical
K091996	ORTHOCOR KNEE SYSTEM BASIC	Dec 15, 2009	Substantially Equivalent	Orthocor Medical
K070541	IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II	Dec 11, 2008	Substantially Equivalent	Ivivi Technologies, Inc.
K070931	MODEL PMT850	May 24, 2007	Substantially Equivalent	Promedtek, Inc.
K022404	ACTIBAND	Aug 08, 2002	Substantially Equivalent	Paw, LLC
K972093	REGENESIS MODEL 42	Oct 21, 1997	Substantially Equivalent	Regenesis Biomedical, Inc.
K903675	MAGNETIC RESONANCE THERAPY DEVICE	Jan 17, 1991	Substantially Equivalent	Mrt, Inc.
K882816	PULSAR EM	Apr 27, 1989	Substantially Equivalent	Apex Medical, Inc.