Singapore HSA registration DE0501706
AVANOS Game Ready Med4 Elite System
Singapore·CLASS B·Avanos Medical, Inc.·Registered June 06, 2018Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0501706
- Registration Date
- June 06, 2018
- Change Notification Approval Date
- April 16, 2025
- Retention Due Date
- June 05, 2025
Product description
The Med4 Elite combines cold, heat, contrast, and compression therapies. It is intended to treat postsurgical and acute injuries to reduce edema, swelling and pain for which cold and compression are indicated. It is intended to treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy are indicated. It is intended to be used by, or on the order of, licensed healthcare professionals in rehabilitation facilities, outpatient clinics, and athletic training settings.
Product Owner
- Short Name
- Avanos Medical, Inc.
- Address
- 5405 Windward Parkway, Alpharetta, GA 30004, UNITED STATES
Registrant
- Address
- 101 THOMSON ROAD, UNITED SQUARE, #17-03, SINGAPORE 307591
Importer
- Name
- BMEC PTE LTD
- Address
- 82 UBI AVENUE 4, EDWARD BOUSTEAD CENTRE, #08-01, SINGAPORE 408832
Model information
- Model Name(s)
- Straight Knee Sleeve Articulated Knee Sleeve Elbow Sleeve Ankle Sleeve, Large Ankle Sleeve, Extra Large Shoulder Sleeve, Medium, Right Shoulder Sleeve, Medium, Left Shoulder Sleeve, Large, Right Shoulder Sleeve. Large, Left Back Sleeve Hip/Groin Sleeve, Right Hip/Groin Sleeve. Left Hand/Wrist Sleeve Flexed Elbow Sleeve Half Leg Boot Sleeve. Large Full Leg Boot Sleeve, Large Full Leg Boot Sleeve, Medium Straight Knee ATX Heat Exchanger Articulated Knee ATX Heat Exchanger Elbow ATX Heat Exchanger Ankle ATX Heat Exchanger, Large Ankle ATX Heat Exchanger. Extra Large Shoulder Sleeve ATX Heat Exchanger, Medium, Right Shoulder Sleeve ATX Heat Exchanger, Medium, Left Back ATX Heat Exchanger Hip/Groin ATX Heat Exchanger, Right Hip/Groin ATX Heat Exchanger, Left Hand/Wrist ATX Heat Exchanger Flexed Elbow ATX Heat Exchanger Half Leg Boot ATX Heat Exchanger , Large Full Leg Boot ATX Heat Exchanger, Large Full Leg Boot ATX Heat Exchanger, Medium Straight Knee Wrap wit ATX Articulated Knee Wrap with ATX Elbow Wrap with ATX Ankle Wrap with ATX, Large Ankle Wrap with ATX , Extra Large Shoulder Sleeve with ATX, Medium, Right Shoulder Sleeve Wrap with ATX. Medium. Left Shoulder Sleeve Wrap with ATX. Large, Right Shoulder Sleeve Wrap with ATX, Large, Left Back Wrap with ATX Hip/Groin Wrap with ATX , Right Hip/Groin Assembled Wrap with ATX. Left Hand/Wrist Wrap with ATX Flexed Elbow Wrap with ATX Half Leg Boot Wrap with ATX , Large Full Leg Boot Wrap with ATX, Large Full Leg Boot Wrap with ATX, Medium Med4Elite System, English, UK Cord
- Model Identifier(s)
- 510100 510160 510200 510330 510340 510422 510424 510432 510434 510500 510602 510604 510811 510903 510906 510922 510923 520100-03 520160-03 520200-03 520330-03 520340-03 520422-03 520424-03 520500-03 520602-03 520604-03 520811-03 520903-03 520906-03 520922-03 520923-03 590100-03 590160-03 590200-03 590330-03 590340-03 590422-03 590424-03 590432-03 590434-03 590500-03 590602-03 590604-03 590811-03 590903-03 590906-03 590922-03 590923-03 650500-EN03
About this record
Access comprehensive regulatory information for AVANOS Game Ready Med4 Elite 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 DE0501706 and owned by Avanos Medical, Inc.. The device was registered on June 06, 2018.
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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