Atlas FDA

ILX

15 FDA 510(k) clearances · Product code

165 daysmedian time to decision
332 days90th percentile
15clearances measured

FDA profile

Official device name
Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5290
Medical specialty
Physical Medicine
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RecordFirmDate
Active System; Avenue8 (K241395)Caerus Corporation2024-12-18
Pulsed electromagnetic field wrap (K202337)Hi-Dow International, Inc.2020-12-15
RecoveryRx (K190251)Bioelectronics Corporation2019-06-28
PROVANT THERAPY SYSTEM (K131979)Regenesis Biomedical, Inc.2013-12-13
ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE (K121702)Orthocor Medical2013-05-06
ZEOBI (K121338)Ivivi Health Science, LLC2012-07-27
PROVANT SYSTEM, MODEL 4201 (K091791)Regenesis Biomedical, Inc.2010-04-07
ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE (K092044)Orthocor Medical2009-12-18
ORTHOCOR KNEE SYSTEM BASIC (K091996)Orthocor Medical2009-12-15
IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II (K070541)Ivivi Technologies, Inc.2008-12-11
MODEL PMT850 (K070931)Promedtek, Inc.2007-05-24
ACTIBAND (K022404)Paw, LLC2002-08-08
REGENESIS MODEL 42 (K972093)Regenesis Biomedical, Inc.1997-10-21
MAGNETIC RESONANCE THERAPY DEVICE (K903675)Mrt, Inc.1991-01-17
PULSAR EM (K882816)Apex Medical, Inc.1989-04-27

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Every clearance here is in the API, with alerts when new ones post.