Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

Device Code: 5092

Product Code(s): IMI

Device Classification Information

• Device Type ID: 5092
• Device Name: Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
• Regulation Description: Ultrasonic Diathermy.
• Regulation Medical Specialty: Physical Medicine
• Review Panel: Physical Medicine
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Neurological And Physical Medicine Devices (DNPMD); Physical Medicine And Rehabilitation Devices Branch (PMDB)
• Submission Type: 510(k)
• CFR Regulation Number: 890.5300 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: IMI
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 12-275 IEC 61161 Edition 3.0 2013-01
  Ultrasonics -- Power Measurement -- Radiation Force Balances And Performance Requirements
• 12-313 IEC TS 62462 Edition 2.0 2017-07
  Ultrasonics - Output Test - Guide For The Maintenance Of Ultrasound Physiotherapy Systems

Total Product Life Cycle

• Device Type ID: 5092
• Device: Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
• Product Code: IMI
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Ultrasonic Diathermy.
• CFR Regulation Number: 890.5300 [🔎]

Premarket Reviews
Manufacturer	Decision
ALMA LASERS INC.
	SUBSTANTIALLY EQUIVALENT	1
BONUTTI RESEARCH, INC.
	SUBSTANTIALLY EQUIVALENT	1
GENERAL PROJECT S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
IBRAMED EQUIPAMENTOS MEDICOS
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Adverse Event Without Identified Device Or Use Problem	6
Communication Or Transmission Problem	1
Total Device Problems	7

TPLC Last Update: 2019-04-02 21:00:07