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510(k) K963461

SAFETY PONCHO/SHOULDER STRAP PONCHO by Skil-Care Corp. — Product Code KID

K963461 is an FDA 510(k) premarket notification submitted by Skil-Care Corp. for the device "SAFETY PONCHO/SHOULDER STRAP PONCHO". The FDA issued a decision of Substantially Equivalent on October 11, 1996. The device falls under product code KID (Restraint, Wheelchair, Non-Protective), 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
October 11, 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)
  • K963459 — SUPPORT VEST (October 15, 1996)
  • K963457 — SLEEPER JACKET/HOUDINI SAFETY SLEEPER (October 9, 1996)
  • K963460 — ROLL BELT (October 9, 1996)
  • K963455 — SLEEVED JACKET/SLEEVED JACKET WITH SLIDER CONTROL (October 8, 1996)
  • K963456 — LIMB HOLDERS-REUSABLE/LIMB HOLDERS-DISPOSABLE/QUICK-CUFF LIMB HOLDER (October 8, 1996)
  • K963454 — CUSHION BELT/CUSHION SLIDER BELT/ADJUSTA-LOOP CUSHION BELT/QUICK RELEASE CUSHION (October 7, 1996)
  • K963450 — SAFETY VEST/SHOULDER STRAP VEST/ECONOMY SAFETY VEST (October 7, 1996)

Other clearances for product code KID

  • K963479 — WHEELCHAIR BELT (January 24, 1997)
  • K963475 — PONCHO VEST RESTRAINT (January 22, 1997)
  • K963480 — MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER (January 22, 1997)
  • K963459 — SUPPORT VEST (October 15, 1996)
  • K963455 — SLEEVED JACKET/SLEEVED JACKET WITH SLIDER CONTROL (October 8, 1996)
  • K802603 — ECONO-FLOAT WHEELCHAIR FLOTATION CUSHION (November 12, 1980)

FDA data resources