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FDA 510(k)

TrueDorsal Devices

K-Number: K180691 · 2019-02-11

ApplicantTrue Function Laboratory, Inc.
Decision Date2019-02-11
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TrueDorsal Devices is the device name listed in this FDA 510(k) record. The listed applicant is True Function Laboratory, Inc.. It received FDA 510(k) clearance on 2019-02-11 under 510(k) number K180691. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TrueDorsal Devices?

TrueDorsal Devices is a medical device that received FDA 510(k) clearance on 2019-02-11. The listed applicant is True Function Laboratory, Inc.. The 510(k) number is K180691.

When did TrueDorsal Devices receive FDA 510(k) clearance?

TrueDorsal Devices received FDA 510(k) clearance on 2019-02-11, under 510(k) number K180691.

Who is the listed applicant for TrueDorsal Devices?

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

What is the FDA product code for TrueDorsal Devices?

The FDA product code for TrueDorsal Devices is LRK.

Other records listing True Function Laboratory, Inc. 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.

K170578True Function Adjustable Herbst Appliances

Related Devices (Code: LRK)

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.

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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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