Singapore HSA registration DE0013615
QAL Medical Orthoagility Lower Extremity Continuous Passive Motion System
Singapore·CLASS B·QAL MEDICAL, LLC·Registered August 14, 2013Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Physical Medicine
- HSA Product Code
- Refer to CRPNS
- HS Code
- 90189030
Registration information
- Registration Number
- DE0013615
- Registration Date
- August 14, 2013
- Retention Due Date
- August 13, 2025
Product description
Intended for the rehabilitation of lower limbs.
Product Owner
- Name
- QAL MEDICAL, LLC
- Short Name
- QAL MEDICAL
- Address
- 3000 WOLESKE ROAD, PO BOX 166, MARINETTE, WISCONSIN 54143, UNITED STATES
Registrant
- Address
- 102F PASIR PANJANG ROAD, CITILINK WAREHOUSE COMPLEX, #07-11, SINGAPORE 118530
Importer
- Address
- 102F PASIR PANJANG ROAD, CITILINK WAREHOUSE COMPLEX, #07-11, SINGAPORE 118530
Model information
- Model Name(s)
- 480E CPM 520 CPM Cradle Knob kit Pediatric foot assembly Bilateral cable, pack of 10 Disposable softgoods kit Disposable softgoods kit A3 CPM Disposable softgoods kit Disposable shoe kit, men Disposable shoe kit, women Motion controller Kit of 10 patient memory keys Power supply L4 CPM Disposable patient kit Hospital bed clamp Bed strap Thigh strap L4 easy transport carriage Stabilizing mattress clamp Standard foot assembly L4D CPM L4K CPM Disposable patient kit L4KD CPM T1 Toe CPM Orthopedic shoe, small Orthopedic shoe, large Metatarsal head isolator, small Metatarsal head isolator, large
- Model Identifier(s)
- 00480EPro 00520 11261 12604 13398-10 480EPK 500PK A3-100U A3-101 A3-103M A3-103W A3-104 GE-107-10 GE102/3 L4-100U L4-101 L4-120 L4-130 L4-140 L4-150 L4-180 L480SA016 L4D-100U L4K-100U L4K-101 L4KD-100U T1-100 T1-101A T1-101C T1-102A T1-102C
About this record
Access comprehensive regulatory information for QAL Medical Orthoagility Lower Extremity Continuous Passive Motion 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 DE0013615 and owned by QAL MEDICAL, LLC. The device was registered on August 14, 2013.
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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