Atlas FDA

IOA

4 FDA 510(k) clearances · Product code

FDA profile

Official device name
Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5275
Medical specialty
Physical Medicine
Flags
Third-party review eligible
Adverse events (MAUDE)
1993: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
DIATHERMY DEVICE-MICROFOCUS (K941567)Cheung Laboratories, Inc.1996-04-22
NEMECTRON MICROWAVE (K895000)Nemectron Medical, Inc.1990-07-27
SIEMENS RADIOTHERM 706, MICROWAVE THERAPY UNIT (K862029)Elmed, Inc.1986-07-16
THERMOTRON 918 (K860082)Medical Microwave Research Corp.1986-03-27

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