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510(k) K792241

PELIMIT by Colmed, Ltd. — Product Code IRN

K792241 is an FDA 510(k) premarket notification submitted by Colmed, Ltd. for the device "PELIMIT". The FDA issued a decision of Substantially Equivalent on November 30, 1979. The device falls under product code IRN (Device, Warning, Overload, External Limb, Powered), a Class II device regulated under 21 CFR 890.5575. Colmed, Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1979
Date Received
November 7, 1979
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 Colmed, Ltd.

  • K811209 — JACOB WIRZ TRANSFIXATION PIN (June 16, 1981)
  • K810636 — VARIODRAIN (May 1, 1981)
  • K810117 — HALOGEN HEADLIGHT SYSTEM (February 10, 1981)
  • K801208 — HOLLOW BASKET TITANIUM DENTAL IMPLANT (May 28, 1980)
  • K801006 — CHARNLEY DESIGN HIP PROSTHESIS (May 20, 1980)
  • K800762 — PS3 TITANIUM SCREW DENTAL IMPLANT (May 14, 1980)

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)
  • K955034 — FORCEGUARD (April 10, 1996)
  • K950656 — PED ALERT (October 25, 1995)
  • K931517 — SAFE-STEP (March 10, 1995)
  • K882974 — FORCE GUARD I (November 4, 1988)
  • K770405 — OVERLOAD WARNING DEVICE (March 10, 1977)

FDA data resources