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510(k) K833195

UMBRELLA WALKER by Convaid Products, Inc. — Product Code ITJ

K833195 is an FDA 510(k) premarket notification submitted by Convaid Products, Inc. for the device "UMBRELLA WALKER". The FDA issued a decision of Substantially Equivalent on October 27, 1983. The device falls under product code ITJ (Walker, Mechanical), a Class I device regulated under 21 CFR 890.3825. Convaid Products, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1983
Date Received
September 19, 1983
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 Convaid Products, Inc.

  • K171017 — Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13 (October 18, 2017)
  • K140416 — TREKKER, TREKKER TRANSIT (September 17, 2014)
  • K120501 — CHAMP CHAMP TRANSIT (September 20, 2012)
  • K032402 — RODEO MODEL, RD12, RD14, RD16, RADIO TRANSIT MODEL, RD12T, RD14T, RD16T, (September 24, 2003)
  • K840250 — CARRIER (February 9, 1984)
  • K822992 — PEOPLE MOVER (October 27, 1982)
  • K810676 — CONVAID CRUISER CP4M (March 26, 1981)
  • K781947 — STROLLER, THERAPY (December 4, 1978)

Other clearances for product code ITJ

  • K833869 — CHILD'S WALKER (November 29, 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)
  • K772049 — WALKING AID (November 11, 1977)

FDA data resources