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510(k) K820711

WALK-A-CYCLE by Walk-A-Cycle Division — Product Code ITJ

K820711 is an FDA 510(k) premarket notification submitted by Walk-A-Cycle Division for the device "WALK-A-CYCLE". The FDA issued a decision of Substantially Equivalent on April 8, 1982. The device falls under product code ITJ (Walker, Mechanical), a Class I device regulated under 21 CFR 890.3825.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1982
Date Received
March 15, 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 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)
  • 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