510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K871647Substantially Equivalent for Some Indications

Stimulator, Ultrasound and Muscle

Amy West, Worcester MA / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K871647 is the FDA 510(k) clearance record for STIMULATOR, ULTRASOUND AND MUSCLE, a class II device, cleared for Amy West on under FDA product code IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat). FDA records list one 510(k) clearance for Amy West. As of , FDA records show no recalls naming K871647.

Clearance record

Decision date
Received
(62 days to decision)
Product code
IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Regulation
21 CFR 890.5860
Device class
Class II
Review panel
Physical Medicine
Applicant
Amy West 419 Main St., Worcester MA
Third party review
No

Clearances, product code IMG

Trailing 12 months

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

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