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510(k) K223019

sam 2.0 Long Ultrasound Device by ZetrOZ Systems, LLC — Product Code PFW

K223019 is an FDA 510(k) premarket notification submitted by ZetrOZ Systems, LLC for the device "sam 2.0 Long Ultrasound Device". The FDA issued a decision of Substantially Equivalent on June 23, 2023. The device falls under product code PFW (Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5300. ZetrOZ Systems, LLC has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2023
Date Received
September 29, 2022
Clearance Type
Traditional
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

  • K260076 — SAM 3.0 Multi-Hour Continuous Ultrasound Device (April 28, 2026)
  • K233210 — sam CS Long Duration Ultrasound Device (October 25, 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

  • K260076 — SAM 3.0 Multi-Hour Continuous Ultrasound Device (April 28, 2026)
  • K233210 — sam CS Long Duration Ultrasound Device (October 25, 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)

FDA data resources