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510(k) K052771

SENSOR WALK by Otto Bock Healthcare LP — Product Code IQI

K052771 is an FDA 510(k) premarket notification submitted by Otto Bock Healthcare LP for the device "SENSOR WALK". The FDA issued a decision of Substantially Equivalent on May 3, 2006. The device falls under product code IQI (Orthosis, Limb Brace), a Class I device regulated under 21 CFR 890.3475. Otto Bock Healthcare LP has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2006
Date Received
September 30, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Limb Brace
Device Class
Class I
Regulation Number
890.3475
Review Panel
PM
Submission Type

Other clearances by Otto Bock Healthcare LP

  • K213587 — MyCRO Band (June 9, 2022)
  • K201426 — MyCRO Band (March 26, 2021)
  • K113164 — DISCOVERY TMAX MANUAL WHEELCHAIR (March 11, 2013)
  • K111278 — Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE (September 16, 2011)
  • K111045 — CENTRO FAMILY OF MANUAL WHEELCHAIRS (July 15, 2011)
  • K101524 — C2000 POWERED WHEELCHAIR (September 29, 2010)
  • K082314 — BRAVORACER PEDIATRIC MANUAL WHEELCHAIR (October 28, 2008)
  • K073512 — START JUNIOR (January 14, 2008)
  • K070318 — SKIPPI POWERED WHEELCHAIR FOR CHILDREN (May 11, 2007)
  • K052706 — A-200 POWERED WHEELCHAIR (December 27, 2005)

Other clearances for product code IQI

  • K143458 — Neurosplint (August 13, 2015)
  • K031576 — SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 (July 31, 2003)
  • K926391 — ACCUFLEX DYNAMIC ELBOW ORTHOSIS (July 22, 1993)
  • K910974 — MCCONNELL SHOULDER BRACE (March 21, 1991)
  • K874502 — GAIT-AID ORTHOPEDIC INSOLE (November 30, 1987)
  • K831542 — ADJUSTABLE POLYCENTRIC ELBOW HINGE (June 24, 1983)
  • K831615 — DROP FOOT BRACE (June 15, 1983)
  • K823812 — VARIOUS SUPPORTS AND SPLINTS (January 14, 1983)
  • K823113 — BRACE-UP ALL PURPOSE WRIST BAND (November 16, 1982)
  • K823160 — ROTATION BOOT (November 10, 1982)

FDA data resources