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510(k) K241395

Device
Active System; Avenue8
Applicant
Caerus Corporation
510(k) number
K241395
Product code
ILX
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-18
Date received
2024-05-16
Regulation
890.5290
Classification name
Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Kai Kroll
Address
8611 W 35w Service Dr. NE Suite 180 Blaine MN US 55449 55449

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ILX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K202337Pulsed electromagnetic field wrapHi-Dow International, Inc.2020-12-15
K190251RecoveryRxBioelectronics Corporation2019-06-28
K131979PROVANT THERAPY SYSTEMRegenesis Biomedical, Inc.2013-12-13
K121702ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICEOrthocor Medical2013-05-06
K121338ZEOBIIvivi Health Science, LLC2012-07-27
K091791PROVANT SYSTEM, MODEL 4201Regenesis Biomedical, Inc.2010-04-07
K092044ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGEOrthocor Medical2009-12-18
K091996ORTHOCOR KNEE SYSTEM BASICOrthocor Medical2009-12-15
K070541IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO IIIvivi Technologies, Inc.2008-12-11
K070931MODEL PMT850Promedtek, Inc.2007-05-24
K022404ACTIBANDPaw, LLC2002-08-08
K972093REGENESIS MODEL 42Regenesis Biomedical, Inc.1997-10-21
K903675MAGNETIC RESONANCE THERAPY DEVICEMrt, Inc.1991-01-17
K882816PULSAR EMApex Medical, Inc.1989-04-27