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510(k) K092793

MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411 by Bio-Medical Research, Ltd. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2009
Date Received
September 11, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cutaneous
Device Class
Class II
Regulation Number
882.1320
Review Panel
NE
Submission Type

Other clearances by Bio-Medical Research, Ltd.

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  • K161974 — SLENDERTONE® Connect Abs, Type 570 (November 1, 2016)
  • K151903 — Slendertone connect Abs (November 6, 2015)
  • K112934 — NEUROTECH RECOVERY (January 20, 2012)
  • K112258 — NEUROTECH PLUS (January 9, 2012)
  • K103031 — BMR FACE (November 10, 2011)
  • K110350 — KNEEHAB XP (August 3, 2011)
  • K102614 — AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40 (June 3, 2011)

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