510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K000084Substantially Equivalent

Enraf-Nonius Sonopuls 190 System

Henley Healthcare, Inc., Sugar Land TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000084 is the FDA 510(k) clearance record for ENRAF-NONIUS SONOPULS 190 SYSTEM, a class II device, cleared for Henley Healthcare, Inc. on under FDA product code IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat). FDA records list 2 510(k) clearances for Henley Healthcare, Inc., from to . As of , FDA records show no recalls naming K000084.

Clearance record

Decision date
Received
(205 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
Henley Healthcare, Inc. 120 Industrial Blvd., Sugar Land TX
510(k) summary
Statement
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