510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K160246Substantially Equivalent

SimulCare II(TM)

Xanacare Technologies, LLC, Denver CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160246 is the FDA 510(k) clearance record for SimulCare II(TM), a class II device, cleared for Xanacare Technologies, LLC on under FDA product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief). FDA records list 3 510(k) clearances for Xanacare Technologies, LLC, from to . As of , FDA records show no recalls naming K160246.

Clearance record

Decision date
Received
(248 days to decision)
Product code
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Regulation
21 CFR 882.5890
Device class
Class II
Review panel
Neurology
Applicant
Xanacare Technologies, LLC 9185 E. Kenyon Ave., Denver CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GZJ

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