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510(k) K801214

HAMILTON TUCKAWAY DESK by Orthopedic Systems, Inc. — Product Code KNO

K801214 is an FDA 510(k) premarket notification submitted by Orthopedic Systems, Inc. for the device "HAMILTON TUCKAWAY DESK". The FDA issued a decision of Substantially Equivalent on May 30, 1980. The device falls under product code KNO (Accessories, Wheelchair), a Class I device regulated under 21 CFR 890.3910. Orthopedic Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1980
Date Received
May 20, 1980
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 Orthopedic Systems, Inc.

  • K952495 — ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM (January 22, 1996)
  • K920256 — SPINE MOTION ANALYZER WITH EMG (August 10, 1992)
  • K910736 — JACKSON MULTIPURPOSE OPERATING TABLE (May 21, 1991)
  • K910031 — PARK CITY SHOULDER POSITIONER (January 24, 1991)
  • K903938 — C FIT CUP (January 4, 1991)
  • K892503 — NUFFIELD TOTAL KNEE (May 4, 1990)
  • K896678 — SILICONE PLUG (January 30, 1990)
  • K894283 — COMPREHENSIVE SPINE MOTION ANALYZER (January 19, 1990)
  • K890331 — FREEMAN TOTAL HIP SYSTEM RIDGED STEM (October 13, 1989)
  • K890498 — FREEMAN MODULAR HIP STEM RIDGED VERSION (October 13, 1989)

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)
  • K823816 — WHEELCHAIR PATIENT RESTRAINTS (January 14, 1983)
  • K823635 — CUSHIONS FOR WHEELCHAIR ARMS (December 28, 1982)
  • K823636 — ARM THROUGH FOR WHEELCHAIR BK-6459-01 & (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)

FDA data resources