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510(k) K823105

RESI-WALKER by Orthion Corp. — Product Code ITJ

K823105 is an FDA 510(k) premarket notification submitted by Orthion Corp. for the device "RESI-WALKER". The FDA issued a decision of Substantially Equivalent on November 5, 1982. The device falls under product code ITJ (Walker, Mechanical), a Class I device regulated under 21 CFR 890.3825. Orthion Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1982
Date Received
October 20, 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 Orthion Corp.

  • K832546 — MARK V HIGH VOLTAGE GALVANIC STIMULATORR (October 14, 1983)
  • K823155 — LAVATORY SEAT HEIGHTENER (November 5, 1982)
  • K823153 — BATH TUB SEAT & BATH BOARD (November 5, 1982)
  • K823154 — SHOWER STOOL W/HANDLES (November 5, 1982)
  • K823149 — OB TILT TABLE (November 5, 1982)
  • K823156 — COLLAPSABLE LAVATORY HEIGHTENER (November 5, 1982)
  • K823150 — SESAM TREATMENT TABLE (November 5, 1982)
  • K823152 — OB HELP ARM (November 5, 1982)
  • K823151 — OB TRIPP TRANSPORT CHAIR (November 5, 1982)
  • K812701 — ORTHO-THERM INFRARED SENSOR (October 13, 1981)

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)
  • 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