Atlas FDA

CES ULTRA

FDA 510(k) clearance K062284 · decided 2007-04-05

Clearance details

K-number
K062284
Device name
CES ULTRA
Applicant
Neuro-Fitness, LLC
Decision
Substantially Equivalent
Date received
2006-08-07
Decision date
2007-04-05
Days to decision
241 days
Clearance type
Traditional
Product code
QJQ
Device class
2
Regulation number
882.5800
Medical specialty
Neurology
Advisory committee
Neurology
Location
Snoqualmie, WA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
CES Ultra, Cranial Electrotherapy Stimulator, Serial Numbers: 1000 through 3999, Manufactu recall (Z-0712-2008)Neuro-Fitness LLC2008-04-08