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FDA 510(k)

COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS

K-Number: K100521 · 2010-05-14

ApplicantMego Afek AC , Ltd.
Decision Date2010-05-14
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Mego Afek AC , Ltd.. It received FDA 510(k) clearance on 2010-05-14 under 510(k) number K100521. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS?

COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS is a medical device that received FDA 510(k) clearance on 2010-05-14. The listed applicant is Mego Afek AC , Ltd.. The 510(k) number is K100521.

When did COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS receive FDA 510(k) clearance?

COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS received FDA 510(k) clearance on 2010-05-14, under 510(k) number K100521.

Who is the listed applicant for COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS?

The FDA 510(k) record lists Mego Afek AC , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS?

The FDA product code for COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS is JOW.

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Related Devices (Code: JOW)

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.

K261807Sequential Circulator (SC-4004-DL, SC-4008-DL)Bio Compression Systems, Inc.K254217AerloomEvolym, LLCK253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile MedicalK253386DVT GarmentVistar Medical Supplies Co., Ltd.K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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