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 the device name listed in this FDA 510(k) record. The listed applicant is Swims America Corp. It received FDA 510(k) clearance on 2023-09-14 under 510(k) 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. The listed applicant is Swims America Corp. The 510(k) number is K230167.

When did BACK 4 receive FDA 510(k) clearance?

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

Who is the listed applicant for BACK 4?

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 4?

The FDA product code for BACK 4 is IPF.

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.

K230037BACK 3 K220014RSHOCK K214090Back 3 COLOR

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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.