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FDA 510(k)

BACK 3

K-Number: K230037 · 2023-07-19

ApplicantSwims America Corp
Decision Date2023-07-19
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BACK 3 is a medical device manufactured by Swims America Corp. It received FDA 510(k) clearance on 2023-07-19 under approval 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. It is manufactured by Swims America Corp. The 510(k) number is K230037.

When was BACK 3 approved by the FDA?

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

What company makes BACK 3?

BACK 3 is manufactured by Swims America Corp.

What is the FDA product code for BACK 3?

The FDA product code for BACK 3 is PBX.

Other Devices by Swims America Corp

K214090Back 3 COLOR K230167BACK 4 K220014RSHOCK

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K162512truSculptCutera, Inc. K161458Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep CareIndiba USA, Inc. K161551TR-100BTL Industries, Inc. K161043Profound SystemSyneron Candela Corporation K160329InMode System MiniFX HandpieceInmode MD , Ltd. K161199EndyMed Contour HandpieceEndymed Medical, Ltd.

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.

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