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510(k) K963475

PONCHO VEST RESTRAINT by Deroyal Industries, Inc. — Product Code KID

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1997
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

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Other clearances for product code KID

  • K963479 — WHEELCHAIR BELT (January 24, 1997)
  • K963480 — MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER (January 22, 1997)
  • K963459 — SUPPORT VEST (October 15, 1996)
  • 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)