CuSP Axheart Portable Defibrillator
The CuSP Axheart is an ultra-compact wearable defibrillator controller for high-risk patients, delivering automatic shocks via vest electrodes for ambulatory protection against ventricular arrhythmias. Battery-powered with event recording. HTS 9018.90.64.00 covers wearable electro-medical defibrillators.
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Alternative Classifications
This product could be classified differently depending on its characteristics or intended use.
If functioning primarily as wearable ECG event recorder without therapeutic shock capability
Monitoring-only wearables classify under diagnostic electro-medical instruments.
If for plastic controller housings sold without electronics
Chapter 90 note 1(f) excludes plastic parts of general use from medical apparatus headings.
If when designed specifically as pacemaker-defibrillator combination implants
Orthopedic appliances include only external support devices; implants have dedicated subheading.
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Import Tips & Compliance
• PMA (Premarket Approval) devices require additional FDA documentation—pre-clear with import alert screening
• Classify garment electrodes separately if bulk packed (HS 6212) vs. complete wearable system
• Ensure HIPAA-compliant data logging specifications in technical files for US privacy compliance
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