510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010745Substantially Equivalent

Ems 3000

Dan Med, Inc., Denver CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010745 is the FDA 510(k) clearance record for EMS 3000, a class II device, cleared for Dan Med, Inc. on under FDA product code IPF (Stimulator, Muscle, Powered). FDA records list 6 510(k) clearances for Dan Med, Inc., from to . As of , FDA records show no recalls naming K010745.

Clearance record

Decision date
Received
(106 days to decision)
Product code
IPF Stimulator, Muscle, Powered
Regulation
21 CFR 890.5850
Device class
Class II
Review panel
Physical Medicine
Applicant
Dan Med, Inc. 4 W. Dry Creek Cir.,, Denver CO
510(k) summary
Statement
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