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

Product Code: ILX

Physical Medicine Microwave Diathermy Machines

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 890.5290


Radiation TypeMicrowave EMF
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as ILX

5082Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep HeatShortwave Diathermy.

Total Product Life Cycle (TPLC) Devices

5082Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep HeatShortwave Diathermy.

Pre-market Notifications for ILX

K202337Pulsed Electromagnetic Field WrapHi-Dow International Inc.
K190251RecoveryRxBioElectronics Corporation
K131979PROVANT THERAPY SYSTEMREGENESIS BIOMEDICAL, INC.
K121702ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICEORTHOCOR MEDICAL
K121338ZEOBIIVIVI HEALTH SCIENCE, LLC
K092044ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGEORTHOCOR MEDICAL
K091996ORTHOCOR KNEE SYSTEM BASICORTHOCOR MEDICAL
K091791PROVANT SYSTEM, MODEL 4201REGENESIS BIOMEDICAL, INC.
K070931MODEL PMT850PROMEDTEK, INC.
K070541IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO IIIVIVI TECHNOLOGIES, INC.
K022404ACTIBANDPAW, LLC
K972093REGENESIS MODEL 42REGENESIS BIOMEDICAL, INC.
K903675MAGNETIC RESONANCE THERAPY DEVICEMRT, INC.
K882816PULSAR EMAPEX MEDICAL, INC.

Global Unique Device Identification Database

00868924000007Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
00851329005050Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
20868924000018Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
00851640007900Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
00851640007931Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
00851640007917Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
00851640007924Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
00868924000021Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
00081009308007Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat

Maude Adverse Events

ACTIPATCHBIOELECTRONICS2016-04-04
PROVANT THERAPY SYSTEMREGENESIS BIOMEDICAL, INC.2011-07-13
PROVANT WOUND THERAPY SYSTEMREGENESIS BIOMEDICAL, INC.2009-03-23
PROVANT WOUND THERAPY SYSTEMREGENESIS BIOMEDICAL, INC.2008-09-18
PROVANT WOUND THERAPY SYSTEMREGENESIS BIOMEDICAL, INC.2008-06-05
ROMA3IVIVI TECHNOLOGIES2007-11-07

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