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510(k) K780935

GRAB BAR by Orthopedic Equipment Co., Inc. — Product Code IKX

K780935 is an FDA 510(k) premarket notification submitted by Orthopedic Equipment Co., Inc. for the device "GRAB BAR". The FDA issued a decision of Substantially Equivalent on June 19, 1978. The device falls under product code IKX (Aid, Transfer), a Class I device regulated under 21 CFR 890.5050. Orthopedic Equipment Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1978
Date Received
June 7, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aid, Transfer
Device Class
Class I
Regulation Number
890.5050
Review Panel
PM
Submission Type

Other clearances by Orthopedic Equipment Co., Inc.

  • K834035 — UNIVERSAL SELF-ALIGNING ACETABULAR COM (June 19, 1984)
  • K841189 — OEC/REZAIAN SPINAL FIXATOR (May 16, 1984)
  • K800530 — SCHLEIN TRI-SURFACE ANKLE (April 2, 1980)
  • K781445 — SPREADER (September 27, 1979)
  • K790247 — TOURNIQUET TEST GAGE (February 26, 1979)
  • K790209 — FILTER SYSTEM, ALTNER DISPOSABLE (February 26, 1979)
  • K781444 — OUTRIGGER DISTRACTION UNIT (September 27, 1978)
  • K781451 — FLAT WRENCH (September 27, 1978)
  • K781447 — THREADED ROD CLAMP (September 27, 1978)
  • K781446 — C RING CLINCHER (September 27, 1978)

Other clearances for product code IKX

  • K862895 — TRICYCLES (August 13, 1986)
  • K842650 — WALL GRAB BARS 98130-98136 (August 10, 1984)
  • K831541 — TUB TRANSFER BENCH BK6481 (June 2, 1983)
  • K823639 — BOARD TO TRANSFER PARALYZED PATIENT FROM (January 21, 1983)
  • K823640 — BATH TUB SAFETY BAR (January 21, 1983)
  • K823634 — CHAIR OR BED LEG EXTENDERS (December 28, 1982)
  • K823154 — SHOWER STOOL W/HANDLES (November 5, 1982)
  • K823153 — BATH TUB SEAT & BATH BOARD (November 5, 1982)
  • K821903 — DISC-O-AID (July 20, 1982)
  • K821010 — BATHTUB TRANSFER BENCH (April 21, 1982)

FDA data resources