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510(k) K960307

INDEX SHOE by Orthopedic Technology Research, Inc. — Product Code IRN

K960307 is an FDA 510(k) premarket notification submitted by Orthopedic Technology Research, Inc. for the device "INDEX SHOE". The FDA issued a decision of Substantially Equivalent on June 27, 1996. The device falls under product code IRN (Device, Warning, Overload, External Limb, Powered), a Class II device regulated under 21 CFR 890.5575. Orthopedic Technology Research, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1996
Date Received
January 22, 1996
Clearance Type
Traditional
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 by Orthopedic Technology Research, Inc.

  • K991313 — ACCUTRED SHOE (June 23, 1999)

Other clearances for product code IRN

  • K060150 — SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM (February 23, 2006)
  • K023161 — SMARTSTEP SYSTEM (December 10, 2002)
  • K991313 — ACCUTRED SHOE (June 23, 1999)
  • K962591 — FOOT WEIGHT ALARM (December 4, 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