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510(k) K821404

LIGHT WEIGHT ALUMINUM WALKER by Manuco Manufacturing Co., Inc. — Product Code ITJ

K821404 is an FDA 510(k) premarket notification submitted by Manuco Manufacturing Co., Inc. for the device "LIGHT WEIGHT ALUMINUM WALKER". The FDA issued a decision of Substantially Equivalent on May 21, 1982. The device falls under product code ITJ (Walker, Mechanical), a Class I device regulated under 21 CFR 890.3825. Manuco Manufacturing Co., Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1982
Date Received
May 11, 1982
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 Manuco Manufacturing Co., Inc.

  • K821403 — LIGHT WEIGHT ALUMINUM CRUTCHES (June 21, 1982)
  • K821405 — MAGUN BASE I.V. POLE (June 16, 1982)
  • K821402 — LIGHT WEIGHT ALUMINUM CANES (April 21, 1982)

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)
  • 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)
  • K772049 — WALKING AID (November 11, 1977)

FDA data resources