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510(k) K823152

OB HELP ARM by Orthion Corp. — Product Code ILE

K823152 is an FDA 510(k) premarket notification submitted by Orthion Corp. for the device "OB HELP ARM". The FDA issued a decision of Substantially Equivalent on November 5, 1982. The device falls under product code ILE (Sling, Arm, Overhead Supported), a Class I device regulated under 21 CFR 890.3475. 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
Sling, Arm, Overhead Supported
Device Class
Class I
Regulation Number
890.3475
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)
  • K823105 — RESI-WALKER (November 5, 1982)
  • K823151 — OB TRIPP TRANSPORT CHAIR (November 5, 1982)
  • K812701 — ORTHO-THERM INFRARED SENSOR (October 13, 1981)

Other clearances for product code ILE

  • K830842 — OB HELP ARM (April 5, 1983)
  • K823811 — OVERHEAD ARM SLINGS (January 14, 1983)

FDA data resources