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510(k) K821402

LIGHT WEIGHT ALUMINUM CANES by Manuco Manufacturing Co., Inc. — Product Code IPS

K821402 is an FDA 510(k) premarket notification submitted by Manuco Manufacturing Co., Inc. for the device "LIGHT WEIGHT ALUMINUM CANES". The FDA issued a decision of Substantially Equivalent on April 21, 1982. The device falls under product code IPS (Cane), a Class I device regulated under 21 CFR 890.3075. Manuco Manufacturing Co., Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1982
Date Received
April 21, 1982
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 Manuco Manufacturing Co., Inc.

  • K821403 — LIGHT WEIGHT ALUMINUM CRUTCHES (June 21, 1982)
  • K821405 — MAGUN BASE I.V. POLE (June 16, 1982)
  • K821404 — LIGHT WEIGHT ALUMINUM WALKER (May 21, 1982)

Other clearances for product code IPS

  • K832970 — CANE REACHER (September 29, 1983)
  • K832969 — WALKING CANE (September 29, 1983)
  • 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)
  • K772267 — QUADRAPLEGIC WALKING AID (December 20, 1977)
  • K770529 — UNICET I (April 5, 1977)

FDA data resources