510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K823388Substantially Equivalent

TENS Max

Fujisawa Electronics Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K823388 is the FDA 510(k) clearance record for TENS MAX, a class II device, cleared for Fujisawa Electronics Co. on under FDA product code GFK (Fibrinogen Determination Standards And Controls). FDA records list one 510(k) clearance for Fujisawa Electronics Co. As of , FDA records show no recalls naming K823388.

Clearance record

Decision date
Received
(54 days to decision)
Product code
GFK Fibrinogen Determination Standards And Controls
Regulation
21 CFR 864.7340
Device class
Class II
Review panel
Hematology
Applicant
Fujisawa Electronics Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GFK

Trailing 12 months

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

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