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FDA 510(k)

welloStationX

K-Number: K180298 · 2018-11-30

ApplicantWello, Inc.
Decision Date2018-11-30
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

welloStationX is a medical device manufactured by Wello, Inc.. It received FDA 510(k) clearance on 2018-11-30 under approval number K180298. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the welloStationX?

welloStationX is a medical device that received FDA 510(k) clearance on 2018-11-30. It is manufactured by Wello, Inc.. The 510(k) number is K180298.

When was welloStationX approved by the FDA?

welloStationX received FDA 510(k) clearance on 2018-11-30, under approval number K180298.

What company makes welloStationX?

welloStationX is manufactured by Wello, Inc..

What is the FDA product code for welloStationX?

The FDA product code for welloStationX is FLL.

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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.

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