510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K040554Substantially Equivalent

Actigraph, Model Am7164-2.2 and Actigraph with Extended Memory, Model Am71256

Manufacturing Technology, Inc., Fort Walton Beach FL / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040554 is the FDA 510(k) clearance record for ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM71256, a class II device, cleared for Manufacturing Technology, Inc. on under FDA product code GWQ (Full-Montage Standard Electroencephalograph). FDA's definition for product code GWQ reads: "Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations". FDA records list one 510(k) clearance for Manufacturing Technology, Inc. As of , FDA records show no recalls naming K040554.

Clearance record

Decision date
Received
(136 days to decision)
Product code
GWQ Full-Montage Standard Electroencephalograph
Regulation
21 CFR 882.1400
Device class
Class II
Review panel
Neurology
Applicant
Manufacturing Technology, Inc. 70 Ready Ave., NW, Fort Walton Beach FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GWQ

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