ShockPhysio Mobile (model SW3200 Basic)— 510(k) K240358

Name: FDA 510(k) clearance K240358
Creator: U.S. Food and Drug Administration
Published: 2024-06-05

Substantially Equivalent

Shenzhen Dongdixin Technology Co., Ltd.

FDA 510(k) clearance K240358 for ShockPhysio Mobile (model SW3200 Basic), Substantially Equivalent on 2024-06-05. Applicant: Shenzhen Dongdixin Technology Co., Ltd.. Device class: 1.

Clearance details

Applicant: Shenzhen Dongdixin Technology Co., Ltd.
Product code: Code ISA
Device class: Class 1
Regulation: 21 CFR 890.5660
Advisory panel: Physical Medicine
Date received: 2024-02-06
Decision date: 2024-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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Adverse events under product code ISA

product code ISA

Death: 3
Other: 1
Total: 4

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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