FDA 510(k)

Contour Hand/Wrist (Q7000232)

K-Number: K233652 · 2024-02-16

Decision Date2024-02-16

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Contour Hand/Wrist (Q7000232) is a medical device manufactured by Quality Electrodynamics. It received FDA 510(k) clearance on 2024-02-16 under approval number K233652. 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 Hand/Wrist (Q7000232)?

Contour Hand/Wrist (Q7000232) is a medical device that received FDA 510(k) clearance on 2024-02-16. It is manufactured by Quality Electrodynamics. The 510(k) number is K233652.

When was Contour Hand/Wrist (Q7000232) approved by the FDA?

Contour Hand/Wrist (Q7000232) received FDA 510(k) clearance on 2024-02-16, under approval number K233652.

What company makes Contour Hand/Wrist (Q7000232)?

Contour Hand/Wrist (Q7000232) is manufactured by Quality Electrodynamics.

What is the FDA product code for Contour Hand/Wrist (Q7000232)?

The FDA product code for Contour Hand/Wrist (Q7000232) is MOS.

Other Devices by Quality Electrodynamics

K233656Contour Shoulder 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.