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FDA 510(k)

THE LEADAWAY

K-Number: K992372 · 1999-10-13

ApplicantTherapy Equipment, Inc.
Decision Date1999-10-13
Product CodeIKD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

THE LEADAWAY is the device name listed in this FDA 510(k) record. The listed applicant is Therapy Equipment, Inc.. It received FDA 510(k) clearance on 1999-10-13 under 510(k) number K992372. The device is classified under product code IKD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE LEADAWAY?

THE LEADAWAY is a medical device that received FDA 510(k) clearance on 1999-10-13. The listed applicant is Therapy Equipment, Inc.. The 510(k) number is K992372.

When did THE LEADAWAY receive FDA 510(k) clearance?

THE LEADAWAY received FDA 510(k) clearance on 1999-10-13, under 510(k) number K992372.

Who is the listed applicant for THE LEADAWAY?

The FDA 510(k) record lists Therapy Equipment, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE LEADAWAY?

The FDA product code for THE LEADAWAY is IKD.

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Related Devices (Code: IKD)

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.

K070926ELECTRODE/EXTENSION CABLES, MODELS ATAROscor, Inc.K935260PHYSIOMETRIX CABLE ADAPTER MODIFICATIONPhysiometrix, Inc.K873361LIFE-SPAN CABLEChemfet Corp.K834583CLEAR LEADS-RADIOTRANSPARENT WIRESQuinton, Inc.K800934R2 ESU CABLE-ADAPTER MODELS 160,161R2 Corp.

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.

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