510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K850006Substantially Equivalent for Some Indications

TENS

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

K850006 is the FDA 510(k) clearance record for TENS, cleared for Zimmer Elektromedizin GmbH on . FDA records list 12 510(k) clearances for Zimmer Elektromedizin GmbH, from to . As of , FDA records show no recalls naming K850006.

Clearance record

Decision date
Received
(352 days to decision)
Review panel
Unknown
Applicant
Zimmer Elektromedizin GmbH Junkersstrabe 9, 7910 Neu-Ulm, Germany, DE
Third party review
No