Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ShockPhysio Mobile (model SW3200 Basic)

K-Number: K240358 · 2024-06-05

ApplicantShenzhen Dongdixin Technology Co., Ltd.
Decision Date2024-06-05
Product CodeISA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ShockPhysio Mobile (model SW3200 Basic) is a medical device manufactured by Shenzhen Dongdixin Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-06-05 under approval number K240358. The device is classified under product code ISA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ShockPhysio Mobile (model SW3200 Basic)?

ShockPhysio Mobile (model SW3200 Basic) is a medical device that received FDA 510(k) clearance on 2024-06-05. It is manufactured by Shenzhen Dongdixin Technology Co., Ltd.. The 510(k) number is K240358.

When was ShockPhysio Mobile (model SW3200 Basic) approved by the FDA?

ShockPhysio Mobile (model SW3200 Basic) received FDA 510(k) clearance on 2024-06-05, under approval number K240358.

What company makes ShockPhysio Mobile (model SW3200 Basic)?

ShockPhysio Mobile (model SW3200 Basic) is manufactured by Shenzhen Dongdixin Technology Co., Ltd..

What is the FDA product code for ShockPhysio Mobile (model SW3200 Basic)?

The FDA product code for ShockPhysio Mobile (model SW3200 Basic) is ISA.

Related Clinical Trials

NCT07232667 Digital Technology for Active and Healthy Ageing in Taiwan RECRUITING NCT07394777 An Open Single-armed Investigation to Evaluate the Safety of pHyph Following a Prolonged Treatment Duration in Adult Women With Bacterial Vaginosis COMPLETED NCT07502937 A Multicenter Interventional Study on the Use of a 3-Degree-of-Freedom (3DOF) Platform to Evaluate the Safety and Usability of the System and Its Impact on Balance, Proprioception, and Neurological Deficits in the Rehabilitation of Patients With Neurological Disorders. NOT_YET_RECRUITING NCT07506967 Early Detection and AI-Based Management of Skin-Related Neglected Tropical Diseases in Sub-Saharan Africa by Frontline Health Workers NOT_YET_RECRUITING

Other Devices by Shenzhen Dongdixin Technology Co., Ltd.

K161735Non-contact Forehead Thermometer K173462Wireless Pain Relieve Device Model: LT5018C K171978Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 K162479Smart Pain Reliever, Model LT5019 K180331Wireless Pain Relieve Device K171430Incontinence Treatment Device, Model LT2061

View all 9 devices →

Related Devices (Code: ISA)

K182682OrthoGold 100Tissue Regeneration Technologies K173692D-Actor 200 Vibration Massage SystemStorz Medical AG K210451OrthoGold 100Tissue Regeneration Technologies, LLC K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt K220538DolorClast RadialE.M.S Electro Medical Systems S.A K221865BTL-094BTL Industries, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑