Singapore HSA registration DE0501220
DJO Intelect Neo Clinical Therapy System
Singapore·CLASS C·DJO, LLC·Registered February 13, 2018Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0501220
- Registration Date
- February 13, 2018
- Change Notification Approval Date
- November 25, 2021
- Retention Due Date
- February 12, 2026
Product description
The Intellect Neo Clinical Therapy System offers electrotherapy, SEMG, STIM, ultrasound and laser therapy. Electrotherapy: Muscle spasm relaxation, prevention/retardation of disuse atrophy, increasing local blood circulation, muscle re-education, maintaining/increasing range of motion,immediate postsurgical muscle stimulation to prevent venous thrombosis, symptomatic relief/management of chronic intractable pain, post-traumatic/post-surgical acute pain, stimulation of partially paralyzed muscle. SEMG & STIM: Stroke rehab by muscle re-education, relaxation of muscle spasm, prevention/retardation of disuse atrophy, increase blood circulation, muscle re-education, maintaining/increasing range of motion and rehabilitation of weak pelvic floor muscles for urinary incontinence. EMG: To determine activation timing for retraining and coordinating of muscle activation, to determine force for relaxation muscle training and muscle re-education.Ultrasound: Treatment of selected sub-chronic and chronic medical conditions such as relief of pain, muscle spasm and joint contracture. Laser:Increasing local blood circulation, relieving minor muscle/joint aches, pain/stiffness, relaxing muscle, relieving muscle spasm, relieving minor pain and stiffness associated with arthritis.
Product Owner
- Name
- DJO, LLC
- Short Name
- DJO, LLC
- Address
- 1430 Decision Street Vista, CA 92081-8553, 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)
- Nylatex Wrap Laser Protective Eyewear Laser Applicator Single LED 670nm 10mW Laser Applicator 33 Diode Cluster Laser Laser Applicator Single Laser 850nm 40mW Laser Applicator Single Laser 850nm 150mW Laser Applicator Single Laser 820nm 300mW Laser Applicator 33 Diode Cluster Laser Laser Applicator 33 Diode Cluster Laser Laser Applicator 33 Diode Cluster Laser Laser Applicator 9 Diode Cluster Laser Laser Applicator 9 Diode Cluster Laser Laser Applicator 9 Diode Cluster Laser Laser Applicator 13 Diode Cluster Laser Laser Applicator 13 Diode Cluster Laser Laser Applicator 19 Diode Cluster Laser Laser Applicator 13 Diode Cluster Laser Laser Applicator Single Laser 850nm 100mW Laser Applicator Single Laser 850nm 200mW Applicator, Ultrasound, Neo Int’l, Small Applicator, Ultrasound, Neo Int’l, Medium Applicator, Ultrasound, Neo Int’l, Large Applicator, Ultrasound, Neo Int’l, Extra Small Dura-Stick Plus 2in. Round Dura-Stick Plus 2in. Round Conductor Transmission Gel Intelect Neo Neo Module STIM Channels 1&2 Neo Cart Neo Module Ultrasoud Neo Module STIM Channels 3&4 Neo Module STIM Channels 1&2 + EMG Neo Module Laser Neo Module Vacuum Intelect Neo Patient Remote STIM CH 1/2 LEADWIRE KIT STD STIM CH3/4 Leadwire Kit Std STIM CH1/2 Leadwire Kit XL Stim Ch 3/4 Leadwire Kit XL Stim Ch 1/2 + EMG Leadwire Kit Powercord UK Black 6 FT Powercord Euro Black 6 FT Powercord Denmark Black 6 FT Powercord South Africa Black 6 FT Powercord Australia Black 6FT Powercord NEMA-15 INTL 6FT Leadhose Vacuum Ch 1/2 Kit Leadhose Vacuum Ch 3/4 Kit Leadhose Vacuum Ch 1/2 Kit XL Leadhose Vacuum Ch 3/4 Kit XL 90 mm Vacuum Electrode Kit 60 mm Vacuum Electrode Kit 30 mm Vacuum Electrode Kit 90 mm Vacuum Sponge Kit 60 mm Vacuum Sponge Kit 30 mm Vacuum Sponge Kit Vac Mod Electrode Leadhose Kit Kit, Vacuum Plug 6x8 cm Carbon Electrodes HiVolt Probe
- Model Identifier(s)
- 10648 27525 27799 27802 27803 27804 27805 27807 27808 27809 27810 27811 27812 27813 27814 27815 27816 27840 27841 28900 28901 28902 28906 42182 42192 4248 6001 70000 70001 70002 70003 70004 70005 70006 70008 70010 70011 70012 70013 70014 70021 70022 70023 70024 70025 70026 70030 70031 70032 70033 70034 70035 70036 70037 70038 70039 70040 70041 79967 79977
About this record
Access comprehensive regulatory information for DJO Intelect Neo Clinical Therapy System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0501220 and owned by DJO, LLC. The device was registered on February 13, 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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