510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K033544Substantially Equivalent

Electrical Muscle Stimulator, Models N605 and N607

Everyway Medical Instruments Co., Ltd., Alpharetta GA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033544 is the FDA 510(k) clearance record for ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607, a class II device, cleared for Everyway Medical Instruments Co.,Ltd on under FDA product code IPF (Stimulator, Muscle, Powered). FDA records list 29 510(k) clearances for Everyway Medical Instruments Co.,Ltd, from to . As of , FDA records show no recalls naming K033544.

Clearance record

Decision date
Received
(30 days to decision)
Product code
IPF Stimulator, Muscle, Powered
Regulation
21 CFR 890.5850
Device class
Class II
Review panel
Physical Medicine
Applicant
Everyway Medical Instruments Co.,Ltd 1308 Morningside Park Dr., Alpharetta GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IPF

Trailing 12 months
3 clearances under product code IPF in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IPF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20262
July 20260
August 20260
September 20260
October 20260