Cleared Traditional

K230167 - BACK 4 (FDA 510(k) Clearance)

K230167 · Swims America Corp · Physical Medicine device

Sep 2023

Decision

237d

Days

Class 2

Risk

K230167 is an FDA 510(k) clearance for the BACK 4. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).

Submitted by Swims America Corp (White Plains, US). The FDA issued a Cleared decision on September 14, 2023, 237 days after receiving the submission on January 20, 2023.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K230167 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 20, 2023
Decision Date	September 14, 2023
Days to Decision	237 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF