510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K843443Substantially Equivalent

Edec-100

Electromed Intl., Ltd., Willoughby OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843443 is the FDA 510(k) clearance record for EDEC-100, a class I device, cleared for Electromed Intl., Ltd. on under FDA product code IZO (Generator, High-Voltage, X-Ray, Diagnostic). FDA records list 23 510(k) clearances for Electromed Intl., Ltd., from to . As of , FDA records show no recalls naming K843443.

Clearance record

Decision date
Received
(178 days to decision)
Product code
IZO Generator, High-Voltage, X-Ray, Diagnostic
Regulation
21 CFR 892.1700
Device class
Class I
Review panel
Radiology
Applicant
Electromed Intl., Ltd. 38201 E. Spaulding St., Willoughby OH
Third party review
No

Clearances, product code IZO

Trailing 12 months

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

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