Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

Product Code: IMI

Physical Medicine Therapeutic Ultrasonic Devices (Certified)

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Applicable Standards: Ultrasonic Therapy Products. [1050.10]

Code of Federal Regulations: 890.5300


Radiation TypeAcoustic
Radition SafetyProduct
Annual ReportsYes

Products Classified as IMI

5092Ultrasonic Diathermy For Use In Applying Therapeutic Deep HeatUltrasonic Diathermy.

Total Product Life Cycle (TPLC) Devices

5092Ultrasonic Diathermy For Use In Applying Therapeutic Deep HeatUltrasonic Diathermy.

FDA Consensus Standards

Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat [32412]21 CFR §890.5300 🔎
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat [37040]21 CFR §890.5300 🔎

Pre-market Notifications for IMI

K202788Sonomed IV, Sonomed VCarci Industria E Comercio De Aparelhos Cirurgicos E Orto
K161628JAS Pulse(TM) Ultrasonic TherapyBonutti Research, Inc.
K161502MC1 PlusGENERAL PROJECT S.R.L.
K160378BRH-A2 Combined Ultrasound And Electric Field Stimulation (CUSEFS)BRH Medical Ltd.
K160075Accent XLAlma Lasers Inc.
K142976UltraTENSShenzhen Dongdixin Technology Co., Ltd
K131309SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZIBRAMED EQUIPAMENTOS MEDICOS
K130888SONOPULSE/ SONOPULSE IIIIBRAMED- INDUSTRIA BRAZILERIA DE EQUIPAMENTOS MEDI
K124010ACCUSONIC ADVANTAGEMETRON MEDICAL AUSTRALIA PTY LTD
K120171ACCUSONIC ADVANTAGEMETRON MEDICAL AUSTRALIA PTY LTD
K112520US-101L, US-103SITO CO., LTD.
K091615MED CONTOURGENERAL PROJECT S.R.L.
K062256HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEMHILL LABORATORIES CO.
K053546SONICATOR 740, MODEL ME 740METTLER ELECTRONICS CORP.
K053041MED SCULPTGENERAL PROJECT S.R.L.

Global Unique Device Identification Database

00816864020272Ultrasonic diathermy for use in applying therapeutic deep heat
00816864020265Ultrasonic diathermy for use in applying therapeutic deep heat
00816864020227Ultrasonic diathermy for use in applying therapeutic deep heat
00092237901731Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
00092237901236Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
00092237901229Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
00092237901212Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
00092237901144Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
00092237901137Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
00092237901083Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
00861681000327Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
00861681000310Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
00861681000303Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
00853904006278Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
00853904006261Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

Maude Adverse Events

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INT LEGEND COMBO 4CDJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.2011-09-30
INTELECT MOBILE COMBODJO GLOBAL2011-09-19
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DYNATRONIS DYNATRONDYNATRONICS2011-09-05
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