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V2U Combo Electrotherapy Device - HSA Registration DE0505280

Access comprehensive regulatory information for V2U Combo Electrotherapy Device in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505280 and owned by V 2 U HEALTHCARE PTE. LTD. The device was registered on December 25, 2020.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0505280
V2U Combo Electrotherapy Device
HSA Registration Number: DE0505280
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Product Description

TENS mode: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. EMS mode: (1) Relaxation of muscle spasms (2) Prevention or retardation of disuse atrophy (3) Muscle re-education (4) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis (5) Maintaining or increasing range of motionโ€ TENS and EMS can be used in the home or hospital, using the object (patient) must be 18 years or older of adults

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0505280
Registration Date
December 25, 2020
Change Notification Approval Date
April 11, 2025
Retention Due Date
December 24, 2025
Product Owner
Short Name
V 2 U HEALTHCARE PTE. LTD
Address
22 SIN MING LANE, MIDVIEW CITY, #07-88, SINGAPORE 573969
Registrant
Address
22 SIN MING LANE, MIDVIEW CITY, #07-88, SINGAPORE 573969
Importer
Address
22 SIN MING LANE, MIDVIEW CITY, #07-88, SINGAPORE 573969
Model Information
Model Name(s)
Combo Electrotherapy Device
Model Identifier(s)
R-C1