Winback Back 3SE
K-Number: K162828 · 2017-09-18
ApplicantWinback USA Corp
Decision Date2017-09-18
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Winback Back 3SE is a medical device manufactured by Winback USA Corp. It received FDA 510(k) clearance on 2017-09-18 under approval number K162828. 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 Winback Back 3SE?
Winback Back 3SE is a medical device that received FDA 510(k) clearance on 2017-09-18. It is manufactured by Winback USA Corp. The 510(k) number is K162828.
When was Winback Back 3SE approved by the FDA?
Winback Back 3SE received FDA 510(k) clearance on 2017-09-18, under approval number K162828.
What company makes Winback Back 3SE?
Winback Back 3SE is manufactured by Winback USA Corp.
What is the FDA product code for Winback Back 3SE?
The FDA product code for Winback Back 3SE 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.