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510(k) K013244

COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE by Med Gen, Inc. — Product Code FQM

K013244 is an FDA 510(k) premarket notification submitted by Med Gen, Inc. for the device "COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE". The FDA issued a decision of Substantially Equivalent on December 7, 2001. The device falls under product code FQM (Bandage, Elastic), a Class I device regulated under 21 CFR 880.5075. Med Gen, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2001
Date Received
September 28, 2001
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 Med Gen, Inc.

  • K013239 — COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES (November 20, 2001)

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)
  • K952738 — SKIN SAVER SYSTEMS (September 29, 1995)
  • K872868 — ASPEN ESMARK BANDAGE (July 31, 1987)
  • K840107 — TUBE-BANDAGE FOR HUMAN DIGITS 200 (April 25, 1984)
  • K831728 — MEDICALEX (January 9, 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