510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K860758Substantially Equivalent

Vaco Suction Electrode Unit

Zimmer Elektromedizin GmbH, 7910 Neu-Ulm, Germany, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860758 is the FDA 510(k) clearance record for VACO SUCTION ELECTRODE UNIT, a class II device, cleared for Zimmer Elektromedizin GmbH on under FDA product code IPF (Stimulator, Muscle, Powered). FDA records list 12 510(k) clearances for Zimmer Elektromedizin GmbH, from to . As of , FDA records show no recalls naming K860758.

Clearance record

Decision date
Received
(63 days to decision)
Product code
IPF Stimulator, Muscle, Powered
Regulation
21 CFR 890.5850
Device class
Class II
Review panel
Physical Medicine
Applicant
Zimmer Elektromedizin GmbH Junkersstrabe 9, 7910 Neu-Ulm, Germany, DE
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