Back 3 COLOR
K-Number: K214090 · 2022-11-01
ApplicantSwims America Corp
Decision Date2022-11-01
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Back 3 COLOR is a medical device manufactured by Swims America Corp. It received FDA 510(k) clearance on 2022-11-01 under approval number K214090. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Back 3 COLOR?
Back 3 COLOR is a medical device that received FDA 510(k) clearance on 2022-11-01. It is manufactured by Swims America Corp. The 510(k) number is K214090.
When was Back 3 COLOR approved by the FDA?
Back 3 COLOR received FDA 510(k) clearance on 2022-11-01, under approval number K214090.
What company makes Back 3 COLOR?
Back 3 COLOR is manufactured by Swims America Corp.
What is the FDA product code for Back 3 COLOR?
The FDA product code for Back 3 COLOR is PBX.
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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.