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510(k) K790299

FOREARM-CANE by Guardian Products Co., Inc. — Product Code IPS

K790299 is an FDA 510(k) premarket notification submitted by Guardian Products Co., Inc. for the device "FOREARM-CANE". The FDA issued a decision of Substantially Equivalent on February 21, 1979. The device falls under product code IPS (Cane), a Class I device regulated under 21 CFR 890.3075. Guardian Products Co., Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1979
Date Received
February 12, 1979
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 Guardian Products Co., Inc.

  • K915108 — FOLDING WHEELCHAIR (January 13, 1992)
  • K842650 — WALL GRAB BARS 98130-98136 (August 10, 1984)
  • K842649 — BATH TUB TRANSFER CHAIR (August 10, 1984)
  • K842651 — COMMODE CHAIR 98200 (August 7, 1984)
  • K821009 — BATHTUB GRAB BAR (April 21, 1982)
  • K821010 — BATHTUB TRANSFER BENCH (April 21, 1982)
  • K772049 — WALKING AID (November 11, 1977)

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)
  • K780085 — CANE/REACHER (January 30, 1978)
  • K772267 — QUADRAPLEGIC WALKING AID (December 20, 1977)
  • K770529 — UNICET I (April 5, 1977)

FDA data resources