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FDA 510(k), K130978, ZTX ULTRASONIC DIATHERMY DEVICE
FDA 510(k), K130978, ZTX ULTRASONIC DIATHERMY DEVICE
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510(K) Number: K130978
Device Name: ZTX ULTRASONIC DIATHERMY DEVICE
Manufacturer: ZetrOZ INC
Device Classification Name: stationary ultrasonic diathermy device for use in applying therapeutic deep heat
Regulation Number: 890.5300
Classification Product Code: PFW
Date Received: 04/09/2013
Decision Date: 11/06/2013
Regulation Medical Specialty: Physical Medicine
Device Name: ZTX ULTRASONIC DIATHERMY DEVICE
Manufacturer: ZetrOZ INC
Device Classification Name: stationary ultrasonic diathermy device for use in applying therapeutic deep heat
Regulation Number: 890.5300
Classification Product Code: PFW
Date Received: 04/09/2013
Decision Date: 11/06/2013
Regulation Medical Specialty: Physical Medicine
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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