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V2U O-Wave I Shockwave Therapy System - HSA Registration DE0019251

Access comprehensive regulatory information for V2U O-Wave I Shockwave Therapy System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0019251 and owned by V 2 U HEALTHCARE PTE. LTD. The device was registered on May 17, 2017.

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
DE0019251
V2U O-Wave I Shockwave Therapy System
HSA Registration Number: DE0019251
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Product Description

The O-wave I used in the area of adjuvant therapy of chronic and acute join pain and be used by medical staff. Acute: Radial and Ulnar epicondylitis, Tendinitis of Shoulder/Shoulder Problems, Calcific Tendinitis of the Shoulder, Status post muscular injury, Patellar Tendinitis, Patellar Tendinopathy, Achillodynia, Planar Fasciatis, Heel Spur, Myofascial trigger point Neck and Back, Trochantric Bursitis, Periostitis Shin Splint Condition. Chronic: Radial and Ulnar epicondylitis, Tendinitis of Shoulder/Shoulder Problems, Calcific Tendinitis of the Shoulder, Status post muscular injury, Patellar Tendinitis, Patellar Tendinopathy, Achillodynia, Planar Fasciatis, Myofascial trigger point Neck and Back, Trochantric Bursitis, Periostitis Shin Splint Condition

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0019251
Registration Date
May 17, 2017
Change Notification Approval Date
July 07, 2020
Retention Due Date
May 16, 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)
O-wave I O-wave I
Model Identifier(s)
V2U-RPW-PT1 V2U-RPW-PT2