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510(k) K854947

REHABILITATION TABLES by I-Rep, Inc. — Product Code INQ

K854947 is an FDA 510(k) premarket notification submitted by I-Rep, Inc. for the device "REHABILITATION TABLES". The FDA issued a decision of Substantially Equivalent on January 3, 1986. The device falls under product code INQ (Table, Powered), a Class I device regulated under 21 CFR 890.3760. I-Rep, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1986
Date Received
December 10, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Powered
Device Class
Class I
Regulation Number
890.3760
Review Panel
PM
Submission Type

Other clearances by I-Rep, Inc.

  • K930692 — LATHAM TABLE (February 2, 1994)
  • K930691 — ACCUTRAC TRACTION UNIT (July 22, 1993)
  • K861864 — MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT (July 14, 1986)
  • K851690 — ADJUSTABLE TREATMENT TABLES (May 7, 1985)
  • K842268 — VACUPULSE VACUUM UNIT (July 20, 1984)
  • K832940 — ROTAGYM (November 7, 1983)
  • K822906 — PHYSICAL MEDICINE & REHABILITATION EQUIP (October 15, 1982)

Other clearances for product code INQ

  • K960334 — CARDON PHYSICAL THERAPY TABLE MODEL R27116 (February 13, 1996)
  • K960332 — CARDON PHYSICAL THERAPY TABLE MODEL R28598 (February 13, 1996)
  • K960336 — CARDON PHYSICAL THERAPY TABLE MODEL R27645 (February 13, 1996)
  • K960196 — TRI W-G, INC TABLE, TILT/EXAM/TREATMENT MODEL 777 (February 7, 1996)
  • K953621 — EVT-3300 (November 14, 1995)
  • K953622 — PTT 6200 ELEVATION THERAPY TABLE (September 11, 1995)
  • K952357 — THE HILL ADJUSTABLE PODIATRY MODEL (July 6, 1995)
  • K951419 — FLEX D-4000 (June 30, 1995)
  • K952359 — THE HILL ADJUSTABLE HA90C (June 22, 1995)
  • K952356 — THE HILL ADJUSTABLE COUNTERSTRAIN TABLE (June 22, 1995)

FDA data resources