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510(k) K963099

HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKET by Heelbo, Inc. — Product Code FMQ

K963099 is an FDA 510(k) premarket notification submitted by Heelbo, Inc. for the device "HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKET". The FDA issued a decision of Substantially Equivalent on November 1, 1996. The device falls under product code FMQ (Restraint, Protective), a Class I device regulated under 21 CFR 880.6760. Heelbo, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1996
Date Received
August 9, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Restraint, Protective
Device Class
Class I
Regulation Number
880.6760
Review Panel
HO
Submission Type

Other clearances by Heelbo, Inc.

  • K980640 — HEELBO WAIST AND CHEST VEST (May 1, 1998)
  • K963372 — HEELBO ER WRIST RESTRAINT (November 7, 1996)
  • K963060 — HEELBO SECURITY BELT (November 4, 1996)
  • K963041 — HEELBO LIFE JACKET WITH CROTCH SUPPORT (October 31, 1996)
  • K962839 — HEELBO QUILTED LIMB HOLDER WITH BUCKLE AND STRAP (October 18, 1996)
  • K962831 — THE INCH QUILTED LIMB HOLDER WITH QUICK RELEASE SNAP CLOSURE (October 18, 1996)
  • K962834 — HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING, QUICK-RELEASE SNAP, AND STRAP (October 18, 1996)
  • K962832 — HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING AND STRAP (October 18, 1996)
  • K963294 — HEELBO WRAP AROUND VEST (October 11, 1996)
  • K963237 — HEELBO ICU 911 BLAZER SLEEVED JACKET (October 9, 1996)

Other clearances for product code FMQ

  • K110377 — PROTECTIVE RESTRAINT (April 25, 2011)
  • K081264 — STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002 (February 13, 2009)
  • K080448 — CENTURION PROTECTIVE RESTRAINT, SCR SERIES (August 28, 2008)
  • K013239 — COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES (November 20, 2001)
  • K010818 — INFANT LIMB HOLDER, MODELS 306080 & 306081 (May 24, 2001)
  • K010644 — CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025 (May 18, 2001)
  • K991591 — BIOTHANE PATIENT RESTRAINT (July 29, 1999)
  • K982178 — VAGABOND SOFT RESTRAINT SYSTEM (January 26, 1999)
  • K980640 — HEELBO WAIST AND CHEST VEST (May 1, 1998)
  • K972446 — PEDO CUSH PEDO CUDDLE (November 13, 1997)

FDA data resources