Singapore HSA registration DE0013616
QAL Medical Orthoagility Upper 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
- DE0013616
- Registration Date
- August 14, 2013
- Retention Due Date
- August 13, 2025
Product description
Intended for the rehabilitation of upper 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)
- Waveflex CPM Hand splint, child Hand splint, adult VHB adhesive tape Finger clips (8) MP block kit Finger actuator (Large) Finger actuator (Medium) Finger actuator (Small) Glove, Small, Left Glove, Small, Right Glove, Medium, Left Glove, Medium, Right Glove, Large, Left Glove, Large, Right Hand splint assembly with bracket E2 CPM Patient kit replacement pads E3 CPM Soft goods set Wrist insert Nickel cadmium rechargeable battery Battery nicad Finger strips Motion controller Portable CPM chair CPM stand Power supply PS1 CPM Disposable patient softgoods Replacement patient kit for S3D/S3S Replacement patient kit for S3H Power supply for CPM chair Motion controller Portable tripod mount Seat clamp assembly Adaptor kit, portable chair S3 CPM S3 CPM S3 CPM S3 CPM S3 CPM Velcro wrist cuff, bag of 10 Velcro elbow cuff, bag of 25 W2 CPM Disposable patient kit
- Model Identifier(s)
- 6000X 6301 6302 6304 6305 6417 6506 6507 6508 6511 6512 6513 6514 6515 6516 A2-1053B A2E-100U E2-101 E3-100L E3-101 E3P047 EABBB EABBC FBA-006 GC-104 GE-103 GE-106E3 GE102/3 PS1-100U PS1-101 S3-101DS S3-101H S3-102M S3-104 S3-105 S3-105D S3-106 S3D-100U S3D-200U S3H-100U S3S-100U S3S-100U2 S3V001-10 S3V005-25 W2-100U W2-101
About this record
Access comprehensive regulatory information for QAL Medical Orthoagility Upper 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 DE0013616 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B