510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K895398Substantially Equivalent

Bio-Coordinator System

Bio-Harmonizer, Inc., Washington D.C. / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895398 is the FDA 510(k) clearance record for BIO-COORDINATOR SYSTEM, a class II device, cleared for Bio-Harmonizer, Inc. on under FDA product code IKK (System, Isokinetic Testing And Evaluation). FDA records list one 510(k) clearance for Bio-Harmonizer, Inc. As of , FDA records show no recalls naming K895398.

Clearance record

Decision date
Received
(21 days to decision)
Product code
IKK System, Isokinetic Testing And Evaluation
Regulation
21 CFR 890.1925
Device class
Class II
Review panel
Physical Medicine
Applicant
Bio-Harmonizer, Inc. 1330 Connecticut Ave. NW, Washington D.C.
Third party review
No

Clearances, product code IKK

Trailing 12 months

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

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