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510(k) K962591

FOOT WEIGHT ALARM by Cleveland Medical Devices, Inc. — Product Code IRN

K962591 is an FDA 510(k) premarket notification submitted by Cleveland Medical Devices, Inc. for the device "FOOT WEIGHT ALARM". The FDA issued a decision of Substantially Equivalent on December 4, 1996. The device falls under product code IRN (Device, Warning, Overload, External Limb, Powered), a Class II device regulated under 21 CFR 890.5575. Cleveland Medical Devices, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1996
Date Received
July 2, 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 Cleveland Medical Devices, Inc.

  • K063872 — KINESIA (April 6, 2007)
  • K042039 — FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120 (November 17, 2004)
  • K013863 — CRYSTAL MONITOR MODEL 16 (February 19, 2002)
  • K001110 — CRYSTAL-EEG MODEL 15 (July 5, 2000)
  • K970672 — CRYSTAL-EEG MODEL 10 (MODEL 10) (May 22, 1997)
  • K964690 — LIBERTY VALVE (March 21, 1997)
  • K954670 — PRESSORE MONITOR (October 30, 1995)

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)
  • 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