Cleared Traditional

ShockPhysio Mobile (model SW3200 Basic)

K240358 · Shenzhen Dongdixin Technology Co., Ltd. · Physical Medicine
Jun 2024
Decision
120d
Days
Class 1
Risk

About This 510(k) Submission

K240358 is an FDA 510(k) clearance for the ShockPhysio Mobile (model SW3200 Basic), a Massager, Therapeutic, Electric (Class I — General Controls, product code ISA), submitted by Shenzhen Dongdixin Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 5, 2024, 120 days after receiving the submission on February 6, 2024. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5660.

Submission Details

510(k) Number K240358 FDA.gov
FDA Decision Cleared SESE
Date Received February 06, 2024
Decision Date June 05, 2024
Days to Decision 120 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code ISA — Massager, Therapeutic, Electric
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5660