510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K221471Substantially Equivalent

E3 and Profile

Diagnosys LLC, Lowell MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K221471 is the FDA 510(k) clearance record for E3 and Profile, a class II device, cleared for Diagnosys, LLC on under FDA product code GWE (Stimulator, Photic, Evoked Response). FDA records list one 510(k) clearance for Diagnosys, LLC. As of , FDA records show no recalls naming K221471.

Clearance record

Decision date
Received
(186 days to decision)
Product code
GWE Stimulator, Photic, Evoked Response
Regulation
21 CFR 882.1890
Device class
Class II
Review panel
Neurology
Applicant
Diagnosys, LLC 55 Technology Dr., Suite 100, Lowell MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GWE

Trailing 12 months

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

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