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

Device Code: 5218

Product Code(s): LXF

Device Classification Information

• Device Type ID: 5218
• Device Name: Diathermy, Ultrasonic, For Use Other Than 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: PMA
• CFR Regulation Number: 890.5300 [🔎]
• FDA Device Classification: Class 3 Medical Device
• Product Code: LXF
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

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: 5218
• Device: Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat
• Product Code: LXF
• FDA Device Classification: Class 3 Medical Device
• Regulation Description: Ultrasonic Diathermy.
• CFR Regulation Number: 890.5300 [🔎]

TPLC Last Update: 2019-04-02 21:02:17