510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K103343Substantially Equivalent

L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right, Left)

Bioness, Inc., Valencia CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103343 is the FDA 510(k) clearance record for L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT), a class II device, cleared for Bioness, Inc. on under FDA product code GZI (Stimulator, Neuromuscular, External Functional). FDA records list 13 510(k) clearances for Bioness, Inc., from to . As of , FDA records show no recalls naming K103343.

Clearance record

Decision date
Received
(165 days to decision)
Product code
GZI Stimulator, Neuromuscular, External Functional
Regulation
21 CFR 882.5810
Device class
Class II
Review panel
Neurology
Applicant
Bioness, Inc. 25103 Rye Canyon Loop, Valencia CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GZI

Trailing 12 months

FDA records hold no clearances under product code GZI in the trailing twelve months.

FDA records show no clearances under product code GZI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GZI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260