Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat

Product Code: PFW

Physical Medicine Therapeutic Ultrasonic Devices (Certified)

Definition: Ultrasonic Diathermy Devices Which Include Stationary Applicators Enabling Hands-free Operation.

Applicable Standards: Ultrasonic Therapy Products. [1050.10]

Code of Federal Regulations: 890.5300

• Radiation Type: Acoustic
• Radition Safety: Product
• Annual Reports: Yes

Products Classified as PFW

5240

Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat

Ultrasonic Diathermy.

Total Product Life Cycle (TPLC) Devices

5240

Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat

Ultrasonic Diathermy.

FDA Consensus Standards

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

Pre-market Notifications for PFW

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K211513	Sam X1 Long Duration Ultrasound Device	ZetrOZ Systems, LLC
K191568	Sam 2.0 Long Duration Ultrasound System	ZetrOZ Systems, LLC
K130978	ZTX ULTRASONIC DIATHERMY DEVICE	ZetrOZ INC
K081075	PAINSHIELD MD	NANO VIBRONIX LTD.
K072256	HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL	HILL LABORATORIES CO.

Global Unique Device Identification Database

• 00857599005097: Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
• 00857599005073: Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
• 07290103421236: Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
• 07290103421168: Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
• 00857599005196: Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
• 07290103421311: Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
• 07290103421267: Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
• 00857599005202: Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
• 07290103421014: Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
• 07290103422035: Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
• 07290103422028: Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
• 07290103421328: Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
• 07290103421144: Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
• 07290103422011: Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat