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510(k) K955034

FORCEGUARD by Impact Monitors, Inc. — Product Code IRN

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

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  • 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)