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510(k) K063642

FD EMS, MODEL # D-FJ30E by Fuji Dynamics Limited — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2007
Date Received
December 7, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type

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  • K041164 — L-TENS (May 20, 2004)
  • K994266 — FDTENS 2010 (July 6, 2000)
  • K994265 — MEDISANA DIGITAL TENS (July 6, 2000)

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