FDA 510(k)

8ch Knee-Foot SPEEDER

K-Number: K162946 · 2017-01-06

Decision Date2017-01-06

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

8ch Knee-Foot SPEEDER is a medical device manufactured by Quality Electrodynamics, LLC. It received FDA 510(k) clearance on 2017-01-06 under approval number K162946. 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 8ch Knee-Foot SPEEDER?

8ch Knee-Foot SPEEDER is a medical device that received FDA 510(k) clearance on 2017-01-06. It is manufactured by Quality Electrodynamics, LLC. The 510(k) number is K162946.

When was 8ch Knee-Foot SPEEDER approved by the FDA?

8ch Knee-Foot SPEEDER received FDA 510(k) clearance on 2017-01-06, under approval number K162946.

What company makes 8ch Knee-Foot SPEEDER?

8ch Knee-Foot SPEEDER is manufactured by Quality Electrodynamics, LLC.

What is the FDA product code for 8ch Knee-Foot SPEEDER?

The FDA product code for 8ch Knee-Foot SPEEDER is MOS.

Other Devices by Quality Electrodynamics, LLC

K16262316ch T/R Hand Wrist Coil K162966TxRx Knee 15 Flare MR Coil 1.5T K163066TxRx Knee 15 Flare MR Coil 3.0T K16202916ch T/R Knee Coil K16119316ch Tx/Rx Knee SPEEDER K173446Contour 24

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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.