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510(k) K963475

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

K963475 is an FDA 510(k) premarket notification submitted by Deroyal Industries, Inc. for the device "PONCHO VEST RESTRAINT". The FDA issued a decision of Substantially Equivalent on January 22, 1997. The device falls under product code KID (Restraint, Wheelchair, Non-Protective), a Class I device regulated under 21 CFR 890.3910. Deroyal Industries, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Deroyal Industries, Inc.

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  • K200631 — DeRoyal Temperature Monitoring Probe (December 23, 2020)
  • K200757 — Foley Catheter with Temperature Sensor (October 15, 2020)
  • K200319 — HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Su (April 2, 2020)
  • K193027 — Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal St (April 2, 2020)
  • K191425 — Hydro-Temp Neonatal Skin Temperature Probe Cover (January 21, 2020)
  • K173072 — Algidex Ag Silver Alginate Wound Dressing (April 4, 2018)
  • K171475 — DeRoyal Laprador Specimen Retrieval System (August 17, 2017)
  • K152978 — DeRoyal Angiography Kits (March 25, 2016)

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)

FDA data resources