FDA 510(k)

Contour Shoulder

K-Number: K233656 · 2024-02-15

Decision Date2024-02-15

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Contour Shoulder is a medical device manufactured by Quality Electrodynamics. It received FDA 510(k) clearance on 2024-02-15 under approval number K233656. 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 Contour Shoulder?

Contour Shoulder is a medical device that received FDA 510(k) clearance on 2024-02-15. It is manufactured by Quality Electrodynamics. The 510(k) number is K233656.

When was Contour Shoulder approved by the FDA?

Contour Shoulder received FDA 510(k) clearance on 2024-02-15, under approval number K233656.

What company makes Contour Shoulder?

Contour Shoulder is manufactured by Quality Electrodynamics.

What is the FDA product code for Contour Shoulder?

The FDA product code for Contour Shoulder is MOS.

Other Devices by Quality Electrodynamics

K233652Contour Hand/Wrist (Q7000232) K24405416ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)

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

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