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510(k) K963459

SUPPORT VEST by Skil-Care Corp. — Product Code KID

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1996
Date Received
September 3, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Restraint, Wheelchair, Non-Protective
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)
  • K963461 — SAFETY PONCHO/SHOULDER STRAP PONCHO (October 11, 1996)
  • K963457 — SLEEPER JACKET/HOUDINI SAFETY SLEEPER (October 9, 1996)
  • K963460 — ROLL BELT (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)
  • K963450 — SAFETY VEST/SHOULDER STRAP VEST/ECONOMY SAFETY VEST (October 7, 1996)
  • K963449 — PELVIC HOLDER (October 7, 1996)

Other clearances for product code KID

  • K963479 — WHEELCHAIR BELT (January 24, 1997)
  • K963480 — MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER (January 22, 1997)
  • K963475 — PONCHO VEST RESTRAINT (January 22, 1997)
  • K963461 — SAFETY PONCHO/SHOULDER STRAP PONCHO (October 11, 1996)
  • K963455 — SLEEVED JACKET/SLEEVED JACKET WITH SLIDER CONTROL (October 8, 1996)
  • K802603 — ECONO-FLOAT WHEELCHAIR FLOTATION CUSHION (November 12, 1980)