FDA 510(k)

BACK 3

K-Number: K230037 · 2023-07-19

Decision Date2023-07-19

Product CodePBX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

BACK 3 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 2023-07-19 under 510(k) number K230037. 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?

BACK 3 is a medical device that received FDA 510(k) clearance on 2023-07-19. The listed applicant is Swims America Corp. The 510(k) number is K230037.

When did BACK 3 receive FDA 510(k) clearance?

BACK 3 received FDA 510(k) clearance on 2023-07-19, under 510(k) number K230037.

Who is the listed applicant for BACK 3?

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?

The FDA product code for BACK 3 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 K220014RSHOCK K214090Back 3 COLOR

Related Devices (Code: PBX)

K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.K260647SPECCHIOEl.En S.P.A.K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.K252888NeoSculpt PlusS&M Medical Co., Ltd.K250734OptiLUV DevicePollogen, Ltd.K250916WinForth (LM-E470KA)Shenzhen Leaflife Technology Co., Ltd.

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.