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510(k) K823816

WHEELCHAIR PATIENT RESTRAINTS by Danek Medical, Inc. — Product Code KNO

K823816 is an FDA 510(k) premarket notification submitted by Danek Medical, Inc. for the device "WHEELCHAIR PATIENT RESTRAINTS". The FDA issued a decision of Substantially Equivalent on January 14, 1983. The device falls under product code KNO (Accessories, Wheelchair), a Class I device regulated under 21 CFR 890.3910. Danek Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1983
Date Received
December 17, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Wheelchair
Device Class
Class I
Regulation Number
890.3910
Review Panel
PM
Submission Type

Other clearances by Danek Medical, Inc.

  • K994122 — BONE GRAFT WASHER, MODEL 9090114 - 9090118 (February 18, 2000)
  • K993810 — CD HORIZON SPINAL SYSTEM (February 3, 2000)
  • K993855 — ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM (December 15, 1999)
  • K991528 — MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR (May 28, 1999)
  • K990603 — MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM (March 10, 1999)
  • K982875 — MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM (January 19, 1999)
  • K984522 — MODIFICATION OF TSRH SPINAL SYSTEM (January 6, 1999)
  • K982154 — MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM (July 13, 1998)
  • K970599 — TOWNLEY PEDICLE SCREW PLATING SYSTEM (March 20, 1998)
  • K943827 — SPINE FIXATION (February 14, 1996)

Other clearances for product code KNO

  • K870298 — REDMAN ACCESSORIES (February 26, 1987)
  • K823645 — VELCRO STRAPS TO HOLD ARM TO WHEELCHAIR (January 21, 1983)
  • K823646 — FRICTION FEEDER (January 21, 1983)
  • K823636 — ARM THROUGH FOR WHEELCHAIR BK-6459-01 & (December 28, 1982)
  • K823635 — CUSHIONS FOR WHEELCHAIR ARMS (December 28, 1982)
  • K823596 — CLAMP ON HOLDER FOR A GLASS OR CUP (December 22, 1982)
  • K823595 — HEAD SUPPORT FOR WHEELCHAIR (December 22, 1982)
  • K821642 — WHEEL CHAIR ACCESSORIES (June 11, 1982)
  • K820964 — WHEELCHAIR PAL (April 16, 1982)
  • K813627 — BK-6453 RIMMED ACRYLIC LAP TRAY KIT (January 19, 1982)

FDA data resources