Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

8ch Knee-Foot SPEEDER

K-Number: K162946 · 2017-01-06

ApplicantQuality Electrodynamics, LLC
Decision Date2017-01-06
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

8ch Knee-Foot SPEEDER is the device name listed in this FDA 510(k) record. The listed applicant is Quality Electrodynamics, LLC. It received FDA 510(k) clearance on 2017-01-06 under 510(k) 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. The listed applicant is Quality Electrodynamics, LLC. The 510(k) number is K162946.

When did 8ch Knee-Foot SPEEDER receive FDA 510(k) clearance?

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

Who is the listed applicant for 8ch Knee-Foot SPEEDER?

The FDA 510(k) record lists Quality Electrodynamics, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Quality Electrodynamics, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K24405416ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)K242006SureWave Elastography (Q7000225)K233652Contour Hand/Wrist (Q7000232)K233656Contour ShoulderK223429Contour KneeK200477Flex Body Speeder

View all 17 devices →

Related Devices (Code: MOS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0TPhilips Medical Systems Nederland B.V.K262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0TPhilips Medical Systems Nederland B.V.K2609470.55T 12Ch Breast CoilNeocoil, LLCK252587HD 8Ch Wrist ArrayShenzhen RF Tech Co., Ltd.K252876GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive OnlyShenzhen RF Tech Co., Ltd.K260519Smart Fit TorsoCardiac 1.5TPhilips Healthcare (Suzhou) Co., Ltd.

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.

↑