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510(k) K800208

SKIL-CARE LEG PADS by Skil-Care Corp. — Product Code KNO

K800208 is an FDA 510(k) premarket notification submitted by Skil-Care Corp. for the device "SKIL-CARE LEG PADS". The FDA issued a decision of Substantially Equivalent on February 21, 1980. The device falls under product code KNO (Accessories, Wheelchair), a Class I device regulated under 21 CFR 890.3910. Skil-Care Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1980
Date Received
February 1, 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 Skil-Care Corp.

  • K010818 — INFANT LIMB HOLDER, MODELS 306080 & 306081 (May 24, 2001)
  • K010644 — CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025 (May 18, 2001)
  • K963458 — PADDED MITTS/PADDED-PLUS MITTS/FINGER SEPARATOR PADDED MITTS/RIGID PALM PADDED M (October 18, 1996)
  • K963459 — SUPPORT VEST (October 15, 1996)
  • K963461 — SAFETY PONCHO/SHOULDER STRAP PONCHO (October 11, 1996)
  • K963460 — ROLL BELT (October 9, 1996)
  • K963457 — SLEEPER JACKET/HOUDINI SAFETY SLEEPER (October 9, 1996)
  • K963456 — LIMB HOLDERS-REUSABLE/LIMB HOLDERS-DISPOSABLE/QUICK-CUFF LIMB HOLDER (October 8, 1996)
  • K963455 — SLEEVED JACKET/SLEEVED JACKET WITH SLIDER CONTROL (October 8, 1996)
  • K963454 — CUSHION BELT/CUSHION SLIDER BELT/ADJUSTA-LOOP CUSHION BELT/QUICK RELEASE CUSHION (October 7, 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)
  • K823816 — WHEELCHAIR PATIENT RESTRAINTS (January 14, 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)

FDA data resources