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510(k) K060150

SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM by Andante Medical Devices , Ltd. — Product Code IRN

K060150 is an FDA 510(k) premarket notification submitted by Andante Medical Devices , Ltd. for the device "SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM". The FDA issued a decision of Substantially Equivalent on February 23, 2006. The device falls under product code IRN (Device, Warning, Overload, External Limb, Powered), a Class II device regulated under 21 CFR 890.5575.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2006
Date Received
January 20, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Warning, Overload, External Limb, Powered
Device Class
Class II
Regulation Number
890.5575
Review Panel
PM
Submission Type

Other clearances for product code IRN

  • K023161 — SMARTSTEP SYSTEM (December 10, 2002)
  • K991313 — ACCUTRED SHOE (June 23, 1999)
  • K962591 — FOOT WEIGHT ALARM (December 4, 1996)
  • K960307 — INDEX SHOE (June 27, 1996)
  • K955034 — FORCEGUARD (April 10, 1996)
  • K950656 — PED ALERT (October 25, 1995)
  • K931517 — SAFE-STEP (March 10, 1995)
  • K882974 — FORCE GUARD I (November 4, 1988)
  • K792241 — PELIMIT (November 30, 1979)
  • K770405 — OVERLOAD WARNING DEVICE (March 10, 1977)

FDA data resources