FDA 510(k)

BACK 4

K-Number: K230167 · 2023-09-14

Decision Date2023-09-14

Product CodeIPF

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

BACK 4 is a medical device manufactured by Swims America Corp. It received FDA 510(k) clearance on 2023-09-14 under approval number K230167. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BACK 4?

BACK 4 is a medical device that received FDA 510(k) clearance on 2023-09-14. It is manufactured by Swims America Corp. The 510(k) number is K230167.

When was BACK 4 approved by the FDA?

BACK 4 received FDA 510(k) clearance on 2023-09-14, under approval number K230167.

What company makes BACK 4?

BACK 4 is manufactured by Swims America Corp.

What is the FDA product code for BACK 4?

The FDA product code for BACK 4 is IPF.

Other Devices by Swims America Corp

K214090Back 3 COLOR K230037BACK 3 K220014RSHOCK

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K160614Xcite Clinical StationRestorative Therapies, Inc. K163067CyMedica e-vive System; CY-1000Cymedica Orthopedics, Inc. K160992HPM-6000BTL Industries, Inc. K151922StimSox(TM) SystemStimmed, LLC K153696Chattanooga Revolution WirelessDjo, LLC K160299geko(TM) Plus R-2 Neuromuscular StimulatorFirstkind Limited

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.