510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862029Substantially Equivalent

Siemens Radiotherm 706, Microwave Therapy Unit

Elmed, Inc., Addison IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862029 is the FDA 510(k) clearance record for SIEMENS RADIOTHERM 706, MICROWAVE THERAPY UNIT, a class II device, cleared for Elmed, Inc. on under FDA product code IOA (Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat). FDA records list 15 510(k) clearances for Elmed, Inc., from to . As of , FDA records show no recalls naming K862029.

Clearance record

Decision date
Received
(49 days to decision)
Product code
IOA Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat
Regulation
21 CFR 890.5275
Device class
Class II
Review panel
Physical Medicine
Applicant
Elmed, Inc. 60 W. Fay Ave., Addison IL
Third party review
No

Clearances, product code IOA

Trailing 12 months

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

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