FDA 510(k)

Flex Body SPEEDER

K-Number: K193140 · 2020-01-03

Decision Date2020-01-03

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Flex Body SPEEDER is a medical device manufactured by Quality Electrodynamics, LLC. It received FDA 510(k) clearance on 2020-01-03 under approval number K193140. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Flex Body SPEEDER?

Flex Body SPEEDER is a medical device that received FDA 510(k) clearance on 2020-01-03. It is manufactured by Quality Electrodynamics, LLC. The 510(k) number is K193140.

When was Flex Body SPEEDER approved by the FDA?

Flex Body SPEEDER received FDA 510(k) clearance on 2020-01-03, under approval number K193140.

What company makes Flex Body SPEEDER?

Flex Body SPEEDER is manufactured by Quality Electrodynamics, LLC.

What is the FDA product code for Flex Body SPEEDER?

The FDA product code for Flex Body SPEEDER is MOS.

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Related Devices (Code: MOS)

K16262316ch T/R Hand Wrist CoilQuality Electrodynamics, LLC K162966TxRx Knee 15 Flare MR Coil 1.5TQuality Electrodynamics, LLC K163066TxRx Knee 15 Flare MR Coil 3.0TQuality Electrodynamics, LLC K162863dS Small Extremity 16CH 1.5T CoilInvivo Therapeutics Corporation K16202916ch T/R Knee CoilQuality Electrodynamics, LLC K162079TRILLIUM Oval Head Coil 32Hitachi Medical Systems America, Inc.

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.