FDA 510(k)

Winback Back 3SE

K-Number: K162828 · 2017-09-18

Decision Date2017-09-18

Product CodePBX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Winback Back 3SE is the device name listed in this FDA 510(k) record. The listed applicant is Winback USA Corp. It received FDA 510(k) clearance on 2017-09-18 under 510(k) 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. The listed applicant is Winback USA Corp. The 510(k) number is K162828.

When did Winback Back 3SE receive FDA 510(k) clearance?

Winback Back 3SE received FDA 510(k) clearance on 2017-09-18, under 510(k) number K162828.

Who is the listed applicant for Winback Back 3SE?

The FDA 510(k) record lists Winback USA Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Winback Back 3SE?

The FDA product code for Winback Back 3SE is PBX.

Related Devices (Code: PBX)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.