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510(k) K812473

HEAD PROTECTOR by Maddak, Inc. — Product Code FMQ

K812473 is an FDA 510(k) premarket notification submitted by Maddak, Inc. for the device "HEAD PROTECTOR". The FDA issued a decision of Substantially Equivalent on December 2, 1981. The device falls under product code FMQ (Restraint, Protective), a Class I device regulated under 21 CFR 880.6760. Maddak, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 1981
Date Received
August 31, 1981
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 Maddak, Inc.

  • K841700 — WALK & ROLL (May 11, 1984)
  • K841698 — HEAT PACK (May 10, 1984)
  • K841695 — CRAWLER (May 10, 1984)
  • K841697 — HYDRO-THERO PAD (May 9, 1984)
  • K841693 — STANDING FRAME (May 9, 1984)
  • K841692 — PRONE STANDER (May 9, 1984)
  • K841691 — SPLIT SEAT POSITIONING CHAIR (May 9, 1984)
  • K834311 — NIGHT TRAINER (March 30, 1984)
  • K833870 — KNEE WALKER (November 29, 1983)
  • K833177 — GLOSSECTOMY FEEDING SPOONS (October 31, 1983)

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