510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K000604Substantially Equivalent

Nature's Chemist Pain Relief Ointment and Therapeutic Ultrasound Coupling Agent

Naturopathic Laboratories International, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000604 is the FDA 510(k) clearance record for NATURE'S CHEMIST PAIN RELIEF OINTMENT AND THERAPEUTIC ULTRASOUND COUPLING AGENT, a class II device, cleared for Naturopathic Laboratories International, Inc. on under FDA product code IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat). FDA records list one 510(k) clearance for Naturopathic Laboratories International, Inc. As of , FDA records show no recalls naming K000604.

Clearance record

Decision date
Received
(90 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
Naturopathic Laboratories International, Inc. 1900 K St. NW, Washington DC
510(k) summary
Summary
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