Singapore HSA registration DE0500656
DJO Chattanooga Intelect RPW Therapy System
Singapore·CLASS B·DJO, LLC·Registered September 15, 2017Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Orthopaedics
Registration information
- Registration Number
- DE0500656
- Registration Date
- September 15, 2017
- Change Notification Approval Date
- November 25, 2021
- Retention Due Date
- September 14, 2025
Product description
The Intelect RPW is intended for the use in predominately non-sterile medical sites. The Intelect RPW allows for the treatment of indications with radial, pneumatically generated, low energy acoustic waves (shock waves) or pressure pulses. The Intelect RPW is designed for the following indications: localizing and deactivating trigger points, increasing circulation, pulse vibration massage, plantar fasciitis, heel pain, or heel spur, tendinosis calcarea/supraspinatus-tendon, radial and ulnar humeral epicondylitis, achillodynia, retropatellar pain syndrome, tibial edge syndrome, proximal iliotibial band friction syndrome/trochanteric insertion tendonitis.
Product Owner
- Name
- DJO, LLC
- Short Name
- DJO, LLC
- Address
- 1430 Decision Street Vista, California 92081, UNITED STATES
Registrant
- Address
- 8 ANGKLONG LANE, FABER GARDEN CONDOMINIUM, #01-03, SINGAPORE 579981
Importer
- Address
- 8 ANGKLONG LANE, FABER GARDEN CONDOMINIUM, #01-03, SINGAPORE 579981
Model information
- Model Name(s)
- R15-15 mm ESWT Transmitter Chattanooga Intelect RPW R-SW Handpiece Applicator D20-S D-ACTOR® 20 mm Transmitter D35 D‐ACTOR® 35 mm Transmitter F15 Focus-Lens 15 mm Transmitter D15 Deep Impact® 15 mm Transmitter C15 CERAma-x® ESWT 15 mm Transmitter V-ACTOR® Hand Piece Applicator Kit Projectile V25 V-ACTOR® 25 mm Vibration Transmitter V40 V-ACTOR® 40 mm Vibration Transmitter
- Model Identifier(s)
- 17638 2074 28699 28724 28725 28726 28728 28729 28730 28736 28740 28741
About this record
Access comprehensive regulatory information for DJO Chattanooga Intelect RPW 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 DE0500656 and owned by DJO, LLC. The device was registered on September 15, 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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