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510(k) K772049

WALKING AID by Guardian Products Co., Inc. — Product Code ITJ

K772049 is an FDA 510(k) premarket notification submitted by Guardian Products Co., Inc. for the device "WALKING AID". The FDA issued a decision of Substantially Equivalent on November 11, 1977. The device falls under product code ITJ (Walker, Mechanical), a Class I device regulated under 21 CFR 890.3825. Guardian Products Co., Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 11, 1977
Date Received
October 31, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Walker, Mechanical
Device Class
Class I
Regulation Number
890.3825
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)
  • K790299 — FOREARM-CANE (February 21, 1979)

Other clearances for product code ITJ

  • K833869 — CHILD'S WALKER (November 29, 1983)
  • K833195 — UMBRELLA WALKER (October 27, 1983)
  • K830784 — WALK N ROLL (May 25, 1983)
  • K830848 — RESI-WALKER (April 5, 1983)
  • K823105 — RESI-WALKER (November 5, 1982)
  • K821404 — LIGHT WEIGHT ALUMINUM WALKER (May 21, 1982)
  • K820711 — WALK-A-CYCLE (April 8, 1982)
  • K811485 — WALKER/CRUTCH BAG (June 16, 1981)
  • K792064 — DELTA ROLLING SELF-LICKING WALKER (October 30, 1979)
  • K790529 — WALKING AID (April 3, 1979)

FDA data resources