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FDA 510(k)

Amputee Garment for use with Lympha Press Optimal Plus

K-Number: K214053 · 2022-04-14

ApplicantMego Afek AC , Ltd.
Decision Date2022-04-14
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Amputee Garment for use with Lympha Press Optimal Plus is a medical device manufactured by Mego Afek AC , Ltd.. It received FDA 510(k) clearance on 2022-04-14 under approval number K214053. 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 Amputee Garment for use with Lympha Press Optimal Plus?

Amputee Garment for use with Lympha Press Optimal Plus is a medical device that received FDA 510(k) clearance on 2022-04-14. It is manufactured by Mego Afek AC , Ltd.. The 510(k) number is K214053.

When was Amputee Garment for use with Lympha Press Optimal Plus approved by the FDA?

Amputee Garment for use with Lympha Press Optimal Plus received FDA 510(k) clearance on 2022-04-14, under approval number K214053.

What company makes Amputee Garment for use with Lympha Press Optimal Plus?

Amputee Garment for use with Lympha Press Optimal Plus is manufactured by Mego Afek AC , Ltd..

What is the FDA product code for Amputee Garment for use with Lympha Press Optimal Plus?

The FDA product code for Amputee Garment for use with Lympha Press Optimal Plus is JOW.

Other Devices by Mego Afek AC , Ltd.

K172277Phlebo Press DVT Model K170658Lympha Press Optimal Plus K163280RP Lite 760R K190493Recovery Pump, 737R (RPX) K190015Ballancer Gold, 1212 K182003Lympha Press Optimal Plus

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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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