510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821511Substantially Equivalent

Powered Muscle Stimulator

High Country Ent., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821511 is the FDA 510(k) clearance record for POWERED MUSCLE STIMULATOR, a class II device, cleared for High Country Ent. on under FDA product code EPF (Hearing Aid, Group And Auditory Trainer). FDA records list one 510(k) clearance for High Country Ent. As of , FDA records show no recalls naming K821511.

Clearance record

Decision date
Received
(88 days to decision)
Product code
EPF Hearing Aid, Group And Auditory Trainer
Regulation
21 CFR 874.3320
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
High Country Ent. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EPF

Trailing 12 months

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

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