Decision Date2018-11-30
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
welloStationX is the device name listed in this FDA 510(k) record. The listed applicant is Wello, Inc.. It received FDA 510(k) clearance on 2018-11-30 under 510(k) 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. The listed applicant is Wello, Inc.. The 510(k) number is K180298.
When did welloStationX receive FDA 510(k) clearance?
welloStationX received FDA 510(k) clearance on 2018-11-30, under 510(k) number K180298.
Who is the listed applicant for welloStationX?
The FDA 510(k) record lists Wello, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for welloStationX?
The FDA product code for welloStationX is FLL.
Related Devices (Code: FLL)
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.