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510(k) K991313

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

K991313 is an FDA 510(k) premarket notification submitted by Orthopedic Technology Research, Inc. for the device "ACCUTRED SHOE". The FDA issued a decision of Substantially Equivalent on June 23, 1999. 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 23, 1999
Date Received
April 16, 1999
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.

  • K960307 — INDEX SHOE (June 27, 1996)

Other clearances for product code IRN

  • K060150 — SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM (February 23, 2006)
  • K023161 — SMARTSTEP SYSTEM (December 10, 2002)
  • 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