510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945286Substantially Equivalent

The Bagnoli-2 EMG System

Delsys Inc., Wellesley MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945286 is the FDA 510(k) clearance record for THE BAGNOLI-2 EMG SYSTEM, a class II device, cleared for Delsys, Inc. on under FDA product code HCC (Device, Biofeedback). FDA records list 3 510(k) clearances for Delsys, Inc., from to . As of , FDA records show no recalls naming K945286.

Clearance record

Decision date
Received
(319 days to decision)
Product code
HCC Device, Biofeedback
Regulation
21 CFR 882.5050
Device class
Class II
Review panel
Neurology
Applicant
Delsys, Inc. 30 Yarmouth Rd., Wellesley MA
510(k) summary
Statement
Third party review
No

Clearances, product code HCC

Trailing 12 months

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

FDA records show no clearances under product code HCC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HCC, 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