510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K221210Substantially Equivalent

PainShield MD PLUS

Nanovibronix, Ltd., Elmsford NY / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K221210 is the FDA 510(k) clearance record for PainShield MD PLUS, a class II device, cleared for Nanovibronix, Inc. on under FDA product code PFW (Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat). FDA's definition for product code PFW reads: "Ultrasonic diathermy devices which include stationary applicators enabling hands-free operation". FDA records list 2 510(k) clearances for Nanovibronix, Inc., from to . As of , FDA records show no recalls naming K221210.

Clearance record

Decision date
Received
(210 days to decision)
Product code
PFW Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
Regulation
21 CFR 890.5300
Device class
Class II
Review panel
Physical Medicine
Applicant
Nanovibronix, Inc. 525 Executive Blvd., Elmsford NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PFW

Trailing 12 months
1 clearance under product code PFW in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PFW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260