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510(k) K221210

PainShield MD PLUS by Nanovibronix, Inc. — Product Code PFW

K221210 is an FDA 510(k) premarket notification submitted by Nanovibronix, Inc. for the device "PainShield MD PLUS". The FDA issued a decision of Substantially Equivalent on November 23, 2022. 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. Nanovibronix, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2022
Date Received
April 27, 2022
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 Nanovibronix, Inc.

  • K111949 — AC WOUND TREATMENT SYSTEM (June 29, 2012)

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)
  • 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)
  • 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