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510(k) K213587

MyCRO Band by Otto Bock Healthcare LP — Product Code MVA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2022
Date Received
November 12, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Cranial
Device Class
Class II
Regulation Number
882.5970
Review Panel
NE
Submission Type

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  • 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)
  • K052771 — SENSOR WALK (May 3, 2006)
  • K052706 — A-200 POWERED WHEELCHAIR (December 27, 2005)

Other clearances for product code MVA

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  • K220681 — Talee, Talee PostOP (September 22, 2022)
  • K203134 — Hanger Cranial Band 3D (July 1, 2022)
  • K193383 — SnugKap (June 7, 2021)
  • K201426 — MyCRO Band (March 26, 2021)
  • K180568 — KidCap (October 16, 2018)
  • K141842 — STARBAND, STARLIGHT (October 6, 2014)
  • K140353 — STARBAND AND STARLIGHT (June 6, 2014)