Singapore HSA registration DE0014738
DJO OptiFlex 3 Continuous Passive Motion Unit
Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Physical Medicine
- HSA Product Code
- HSAMDB00104
- HS Code
- 90191010
Registration information
- Registration Number
- DE0014738
- Registration Date
- February 07, 2014
- Retention Due Date
- February 06, 2026
Product description
Continuous Passive Motion is a postoperative procedure designed to aid in patient recovery after joint surgery. This unit is typically used postoperatively for total knee replacement and Anterior Cruciate Ligament (ACL) repairs. After extensive joint surgery, if a patient fails to move the joint, tissue around the joint will become stiff and scar tissue will form, resulting in a joint with limited range of motion. By repeatedly flexing and extending the affected joint through a prescribed arc of motion for an extended period of time, the OptiFlex 3 CPM Unit lessens the adverse effects of immobilization and trauma on the knee joint.
Product Owner
- Name
- DJO, LLC
- Short Name
- DJO, LLC
- Address
- 1430 Decision Street Vista, California 92081, UNITED STATES
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)
- Standard Accessories Optiflex 3 Knee CPM Optional Accessories Standard Accessories
- Model Identifier(s)
- 20533 2090 4520 J2038
About this record
Access comprehensive regulatory information for DJO OptiFlex 3 Continuous Passive Motion Unit in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0014738 and owned by DJO, LLC. The device was registered on February 07, 2014.
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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