510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K943535Substantially Equivalent

Model Me 300 Muscle Tester

Regulatory Strategies, Inc., Eagan MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943535 is the FDA 510(k) clearance record for MODEL ME 300 MUSCLE TESTER, a class II device, cleared for Regulatory Strategies, Inc. on under FDA product code HCC (Device, Biofeedback). FDA records list one 510(k) clearance for Regulatory Strategies, Inc. As of , FDA records show no recalls naming K943535.

Clearance record

Decision date
Received
(1,070 days to decision)
Product code
HCC Device, Biofeedback
Regulation
21 CFR 882.5050
Device class
Class II
Review panel
Neurology
Applicant
Regulatory Strategies, Inc. 1660 Riverton Pt., Eagan MN
510(k) summary
Summary
Third party review
No

Clearances, product code HCC

Trailing 12 months

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

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