Biphasic Waveform Generator PCA for Defibrillators
Advanced printed circuit assembly generating controlled biphasic shock waveforms for improved defibrillation efficacy. Specifically designed for 9018.90.64 defibrillators, qualifying under HTS 9018.90.68.00. Employs high-voltage MOSFET drivers and waveform shaping algorithms per AHA guidelines.
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Alternative Classifications
This product could be classified differently depending on its characteristics or intended use.
If when assembled into complete biphasic defibrillator units
Fully assembled instruments import under the operational electro-medical apparatus heading.
If for general high-voltage pulse generator modules
Other electrical machines for electrotherapy or induction, not dedicated to defibrillation.
If used in oscilloscopes or general signal generators
Waveform generation PCAs for non-medical measuring instruments classify under Chapter 90 measuring apparatus.
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Import Tips & Compliance
• Provide clinical equivalence data comparing waveform performance to predicate defibrillators in 510(k) submissions
• Include high-voltage isolation test results (IEC 60601-1) to substantiate medical electrical safety classification
• Segment invoices by PCA function to match exact HTS subheadings and optimize duty calculations
Related Products under HTS 9018.90.68.00
Defibrillator Control Board PCB
This printed circuit assembly serves as the main control board for external defibrillators, managing power distribution, signal processing, and user interface functions. It falls under HTS 9018.90.68.00 as a dedicated PCA specifically designed for defibrillators classified in 9018.90.64. The board integrates microprocessors and memory chips essential for real-time ECG analysis and shock delivery.
Defibrillator ECG Signal Processing PCA
Printed circuit assembly dedicated to analog-to-digital conversion and filtering of ECG signals in automated external defibrillators (AEDs). Classified under HTS 9018.90.68.00 because it is an integral PCA for subheading 9018.90.64 defibrillators, enabling heart rhythm analysis. Features high-speed ADCs and noise-reduction circuits compliant with IEC 60601 medical standards.
AED Power Management Printed Circuit Board
This PCA handles battery charging, voltage regulation, and capacitor discharge sequencing for automated external defibrillators. It qualifies for HTS 9018.90.68.00 as a specialized printed circuit assembly for 9018.90.64-classified AEDs. Includes safety interlocks preventing unsafe discharge per UL 2601-1 standards.
Defibrillator User Interface Display PCA
Printed circuit assembly driving LCD/LED displays, buttons, and voice prompt circuits in professional defibrillators. Falls under HTS 9018.90.68.00 for its role in subheading 9018.90.64 defibrillator operation, providing CPR feedback and charge status. Integrates touch controllers and audio amplifiers optimized for emergency environments.
Defibrillator Data Logging and Telemetry PCA
Printed circuit assembly for event recording, Bluetooth telemetry, and USB data transfer in modern defibrillators. Classifies under HTS 9018.90.68.00 as PCA for 9018.90.64 instruments, storing up to 500 patient events with HIPAA-compliant encryption. Supports wireless reporting to hospital networks.
Pediatric Defibrillator Dose Attenuation PCA
Specialized PCA implementing pediatric energy dose correction for biphasic defibrillators treating children under 8 years. HTS 9018.90.68.00 classification applies as dedicated assembly for 9018.90.64 defibrillators per AHA pediatric guidelines. Features adaptive algorithms reducing adult shock levels by 50-75%.