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FDA 510(k)

COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE

K-Number: K013244 · 2001-12-07

ApplicantMed Gen, Inc.
Decision Date2001-12-07
Product CodeFQM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE is the device name listed in this FDA 510(k) record. The listed applicant is Med Gen, Inc.. It received FDA 510(k) clearance on 2001-12-07 under 510(k) number K013244. The device is classified under product code FQM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE?

COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE is a medical device that received FDA 510(k) clearance on 2001-12-07. The listed applicant is Med Gen, Inc.. The 510(k) number is K013244.

When did COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE receive FDA 510(k) clearance?

COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE received FDA 510(k) clearance on 2001-12-07, under 510(k) number K013244.

Who is the listed applicant for COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE?

The FDA 510(k) record lists Med Gen, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE?

The FDA product code for COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE is FQM.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Med Gen, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K013239COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES

Related Devices (Code: FQM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K040936PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDELeda Co., Ltd.K040054BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLETheodore BarashK952738SKIN SAVER SYSTEMSSkin Saver Systems, Inc.K872868ASPEN ESMARK BANDAGEAspen Laboratories, Inc.K840107TUBE-BANDAGE FOR HUMAN DIGITS 200Zens Health Care ProductsK831728MEDICALEXMedicalex

Official Source

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