Cleared Traditional

K240358 - ShockPhysio Mobile (model SW3200 Basic)

K240358 is an FDA 510(k) clearance for ShockPhysio Mobile (model SW3200 Basic), manufactured by Shenzhen Dongdixin Technology Co., Ltd.. The device is a Class 1 Physical Medicine device with product code ISA cleared through the Traditional 510(k) pathway after a 120-day FDA review.

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

K240358 is an FDA 510(k) clearance for the ShockPhysio Mobile (model SW3200 Basic). Classified as Massager, Therapeutic, Electric (product code ISA), Class I - General Controls.

Submitted by Shenzhen Dongdixin Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 5, 2024 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5660 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen Dongdixin Technology Co., Ltd. devices

FDA 510(k) Submission Details - K240358

510(k) Number K240358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 115d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

ISA Device Classification - Class 1, General Controls

Product Code ISA Massager, Therapeutic, Electric
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ISA Massager, Therapeutic, Electric

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