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 a medical device manufactured by True Function Laboratory, Inc.. It received FDA 510(k) clearance on 2019-02-11 under approval 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. It is manufactured by True Function Laboratory, Inc.. The 510(k) number is K180691.
When was TrueDorsal Devices approved by the FDA?
TrueDorsal Devices received FDA 510(k) clearance on 2019-02-11, under approval number K180691.
What company makes TrueDorsal Devices?
TrueDorsal Devices is manufactured by True Function Laboratory, Inc..
What is the FDA product code for TrueDorsal Devices?
The FDA product code for TrueDorsal Devices is LRK.
Other Devices by True Function Laboratory, Inc.
Related Devices (Code: LRK)
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.