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510(k) K831728

MEDICALEX by Medicalex — Product Code FQM

K831728 is an FDA 510(k) premarket notification submitted by Medicalex for the device "MEDICALEX". The FDA issued a decision of Substantially Equivalent on January 9, 1984. The device falls under product code FQM (Bandage, Elastic), a Class I device regulated under 21 CFR 880.5075. Medicalex has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1984
Date Received
May 31, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bandage, Elastic
Device Class
Class I
Regulation Number
880.5075
Review Panel
HO
Submission Type

Other clearances by Medicalex

  • K850946 — SURGICAL ASPIRATOR (September 16, 1985)
  • K851349 — LERE NAIL & PLATE COMBIN. ONE PIECE FORGED (May 29, 1985)
  • K833377 — MEDICALEX (September 27, 1984)

Other clearances for product code FQM

  • K040936 — PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE (May 3, 2004)
  • K040054 — BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND A (April 27, 2004)
  • K013244 — COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCA (December 7, 2001)
  • K952738 — SKIN SAVER SYSTEMS (September 29, 1995)
  • K872868 — ASPEN ESMARK BANDAGE (July 31, 1987)
  • K840107 — TUBE-BANDAGE FOR HUMAN DIGITS 200 (April 25, 1984)
  • K830622 — ORTHO WRAP (June 20, 1983)
  • K831551 — COMPRESSOGRIP TUBULAR ELASTIC BANDAGE (June 7, 1983)
  • K820142 — TUBULAR STOCKINETTE (February 5, 1982)
  • K820141 — BIAS STOCKINETTE (February 5, 1982)

FDA data resources