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510(k) K260076

SAM 3.0 Multi-Hour Continuous Ultrasound Device by ZetrOZ Systems, LLC — Product Code PFW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2026
Date Received
January 12, 2026
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5300
Review Panel
PM
Submission Type

Ultrasonic diathermy devices which include stationary applicators enabling hands-free operation.

Other clearances by ZetrOZ Systems, LLC

  • K233210 — sam CS Long Duration Ultrasound Device (October 25, 2023)
  • K223019 — sam 2.0 Long Ultrasound Device (June 23, 2023)
  • K211513 — sam X1 Long Duration Ultrasound Device (August 18, 2021)
  • K191568 — sam 2.0 Long Duration Ultrasound System (March 6, 2020)

Other clearances for product code PFW

  • K233210 — sam CS Long Duration Ultrasound Device (October 25, 2023)
  • K223019 — sam 2.0 Long Ultrasound Device (June 23, 2023)
  • K221210 — PainShield MD PLUS (November 23, 2022)
  • K211513 — sam X1 Long Duration Ultrasound Device (August 18, 2021)
  • K191568 — sam 2.0 Long Duration Ultrasound System (March 6, 2020)
  • K130978 — ZTX ULTRASONIC DIATHERMY DEVICE (November 6, 2013)
  • K081075 — PAINSHIELD MD (August 22, 2008)
  • K072256 — HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM W (March 12, 2008)