BACK 4— 510(k) K230167

Substantially Equivalent

Swims America Corp

FDA 510(k) clearance K230167 for BACK 4, Substantially Equivalent on 2023-09-14. Applicant: Swims America Corp. Device class: 2.

Clearance details

Applicant: Swims America Corp
Product code: Code IPF
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2023-01-20
Decision date: 2023-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: White Plains, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.