510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K131309Substantially Equivalent

Sonopulse Compact 1Mhz, Sonopulse Compact 3Mhz

Ibramed Equipamentos Medicos, Aventura FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K131309 is the FDA 510(k) clearance record for SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ, a class II device, cleared for Ibramed Equipamentos Medicos on under FDA product code IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat). FDA records list 7 510(k) clearances for Ibramed Equipamentos Medicos, from to . As of , FDA records show no recalls naming K131309.

Clearance record

Decision date
Received
(265 days to decision)
Product code
IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Regulation
21 CFR 890.5300
Device class
Class II
Review panel
Physical Medicine
Applicant
Ibramed Equipamentos Medicos 18851 NE 29th Ave., Aventura FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IMI

Trailing 12 months

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

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