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510(k) K955034

FORCEGUARD by Impact Monitors, Inc. — Product Code IRN

K955034 is an FDA 510(k) premarket notification submitted by Impact Monitors, Inc. for the device "FORCEGUARD". The FDA issued a decision of Substantially Equivalent on April 10, 1996. 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
April 10, 1996
Date Received
November 2, 1995
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 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)
  • K960307 — INDEX SHOE (June 27, 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