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510(k) K832546

MARK V HIGH VOLTAGE GALVANIC STIMULATORR by Orthion Corp. — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1983
Date Received
July 29, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type

Other clearances by Orthion Corp.

  • K823150 — SESAM TREATMENT TABLE (November 5, 1982)
  • K823153 — BATH TUB SEAT & BATH BOARD (November 5, 1982)
  • K823151 — OB TRIPP TRANSPORT CHAIR (November 5, 1982)
  • K823155 — LAVATORY SEAT HEIGHTENER (November 5, 1982)
  • K823156 — COLLAPSABLE LAVATORY HEIGHTENER (November 5, 1982)
  • K823154 — SHOWER STOOL W/HANDLES (November 5, 1982)
  • K823149 — OB TILT TABLE (November 5, 1982)
  • K823152 — OB HELP ARM (November 5, 1982)
  • K823105 — RESI-WALKER (November 5, 1982)
  • K812701 — ORTHO-THERM INFRARED SENSOR (October 13, 1981)

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