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510(k) K823149

OB TILT TABLE by Orthion Corp. — Product Code INW

K823149 is an FDA 510(k) premarket notification submitted by Orthion Corp. for the device "OB TILT TABLE". The FDA issued a decision of Substantially Equivalent on November 5, 1982. The device falls under product code INW (Table, Mechanical), a Class I device regulated under 21 CFR 890.3750. 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
Table, Mechanical
Device Class
Class I
Regulation Number
890.3750
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)
  • K823156 — COLLAPSABLE LAVATORY HEIGHTENER (November 5, 1982)
  • K823150 — SESAM TREATMENT TABLE (November 5, 1982)
  • K823152 — OB HELP ARM (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 INW

  • K944308 — JAMES LECKEY FREE STANDER (December 22, 1994)
  • K944307 — JAMES LECKEY PRONE STANDER (December 22, 1994)
  • K943975 — EURO TECH PLATINUM CHIROPRACTIC TABLE (September 29, 1994)
  • K943974 — EURO TECH MARQUISE CHIROPRACTIC TABLE (September 29, 1994)
  • K940238 — TUMBLE FORMS JUNIOR TRISTANDER (March 7, 1994)
  • K932233 — ECONOMY HI-LOW WORK TABLE (MANUAL) MODEL 3405 (July 22, 1993)
  • K932238 — ECO. HI-LOW TREATMENT TABLES VARIOUS MODEL NUMBERS (July 22, 1993)
  • K932231 — ECONOMY HI-LOW MAT TABLE #4110 THRU 4117 (July 22, 1993)
  • K932234 — PROFESSIONAL & ECONMY TILT TABLE 9500 9520 (July 22, 1993)
  • K931635 — TREATMENT TABLES, MANUALLY ACTIVATED (July 21, 1993)

FDA data resources