510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K964083Substantially Equivalent

Ultratherm (908)

Sie-Med, Inc., Clarksville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964083 is the FDA 510(k) clearance record for ULTRATHERM (908), a class II device, cleared for Sie-Med, Inc. on under FDA product code IMJ (Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat). FDA records list 2 510(k) clearances for Sie-Med, Inc., from to . As of , FDA records show no recalls naming K964083.

Clearance record

Decision date
Received
(174 days to decision)
Product code
IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Regulation
21 CFR 890.5290
Device class
Class II
Review panel
Physical Medicine
Applicant
Sie-Med, Inc. 11902 Simpson Rd., Clarksville MD
510(k) summary
Summary
Third party review
No

Clearances, product code IMJ

Trailing 12 months
2 clearances under product code IMJ in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code IMJ, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260