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510(k) K772267

QUADRAPLEGIC WALKING AID by Med Fusion Systems, Inc. — Product Code IPS

K772267 is an FDA 510(k) premarket notification submitted by Med Fusion Systems, Inc. for the device "QUADRAPLEGIC WALKING AID". The FDA issued a decision of Substantially Equivalent on December 20, 1977. The device falls under product code IPS (Cane), a Class I device regulated under 21 CFR 890.3075. Med Fusion Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1977
Date Received
December 9, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cane
Device Class
Class I
Regulation Number
890.3075
Review Panel
PM
Submission Type

Other clearances by Med Fusion Systems, Inc.

  • K873961 — INFUMED 300 AMBULATORY INFUSION PUMP (December 29, 1987)
  • K870524 — AMBULATORY INFUSION PUMP DRUG RESERVOIR (May 6, 1987)
  • K870907 — INTRODUCER, PERCUTANEOUS (April 9, 1987)
  • K864407 — REFILLABLE SYRINGE (January 20, 1987)
  • K863814 — BAG SPIKE EXTENSION SET (October 14, 1986)
  • K860616 — VOLUME CONTROL SET WITH EXTENSION (June 2, 1986)
  • K860803 — IV FILTER EXTENSION SET (April 9, 1986)
  • K844313 — INFUSET W/HUBER NEEDLE (January 22, 1985)
  • K842984 — EXTENSION SET W/INJECTION SITE (October 16, 1984)
  • K842143 — BENT WINGED MINI-VOL INFUSION SET (July 20, 1984)

Other clearances for product code IPS

  • K832970 — CANE REACHER (September 29, 1983)
  • K832969 — WALKING CANE (September 29, 1983)
  • K821402 — LIGHT WEIGHT ALUMINUM CANES (April 21, 1982)
  • K790558 — CERSA-CANE (April 3, 1979)
  • K790561 — OFFSET ALUMINUM CANE (April 3, 1979)
  • K790299 — FOREARM-CANE (February 21, 1979)
  • K780085 — CANE/REACHER (January 30, 1978)
  • K770529 — UNICET I (April 5, 1977)

FDA data resources