FDA 510(k)

Back 3 COLOR

K-Number: K214090 · 2022-11-01

Decision Date2022-11-01

Product CodePBX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Back 3 COLOR is the device name listed in this FDA 510(k) record. The listed applicant is Swims America Corp. It received FDA 510(k) clearance on 2022-11-01 under 510(k) 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. The listed applicant is Swims America Corp. The 510(k) number is K214090.

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

Back 3 COLOR received FDA 510(k) clearance on 2022-11-01, under 510(k) number K214090.

Who is the listed applicant for Back 3 COLOR?

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

What is the FDA product code for Back 3 COLOR?

The FDA product code for Back 3 COLOR is PBX.

Other records listing Swims America Corp as applicant

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.

K230167BACK 4 K230037BACK 3 K220014RSHOCK

Related Devices (Code: PBX)

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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.