510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K946018Substantially Equivalent

TENS-It, Fittronic II, (More Later)

Ems, Inc., Pen Valley CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K946018 is the FDA 510(k) clearance record for TENS-IT, FITTRONIC II, (MORE LATER), a class II device, cleared for Ems, Inc. on under FDA product code GZL (Electrode, Depth). FDA records list 2 510(k) clearances for Ems, Inc., from to . As of , FDA records show no recalls naming K946018.

Clearance record

Decision date
Received
(335 days to decision)
Product code
GZL Electrode, Depth
Regulation
21 CFR 882.1330
Device class
Class II
Review panel
Neurology
Applicant
Ems, Inc. P.O. Drawer 179, Pen Valley CA
510(k) summary
Statement
Third party review
No

Clearances, product code GZL

Trailing 12 months
2 clearances under product code GZL in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GZL, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260