510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861864Substantially Equivalent

Medtron Type P-300 Ultrasonic Therapy Unit

I-Rep, Inc., Lake Elsinore CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861864 is the FDA 510(k) clearance record for MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT, a class II device, cleared for I-Rep, Inc. on under FDA product code IMJ (Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat). FDA records list 5 510(k) clearances for I-Rep, Inc., from to . As of , FDA records show no recalls naming K861864.

Clearance record

Decision date
Received
(60 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
I-Rep, Inc. 29885 Second St. Suite "G", Lake Elsinore CA
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