Regulatory Notice
FDA Registration & Regulatory Information | NovaCare Anti-Choking Device
FDA REGISTRATION & REGULATORY NOTICE
Transparency about our product's regulatory status, manufacturing, and compliance.
Last Updated: December 27, 2025
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COMPANY INFORMATION
Legal Entity: NovaCare Medical LLC
Location: Wilmington, Delaware, United States
Role: Authorized distributor of The NovaCare Anti-Choking Device
Contact: support@novacareus.com
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FDA DEVICE REGISTRATION
The NovaCare Anti-Choking Device is an FDA Class I registered medical device marketed in the United States under the following registration:
Device Class: Class I Medical Device
Regulation Number: 868.6809
Product Code: BSY (Catheters, Suction, Tracheobronchial)
Classification: Anti-Choking Device; Breathing Trainer; Choking First Aid Device
IMPORTANT NOTICE: FDA registration and listing does not constitute FDA approval, clearance, or endorsement of this device. FDA Class I devices are subject to general controls and must comply with applicable federal regulations governing medical device manufacturing, labeling, and marketing.
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MANUFACTURING INFORMATION
Transparency matters to us. Like most leading safety device brands, NovaCare products are manufactured at a specialized, FDA-registered production facility and undergo quality control at every stage.
Manufacturing Facility: FDA-registered device manufacturing facility
FDA Establishment Registration: On file (Foreign Exporter, Manufacturer)
Quality Control: Every device is produced under documented quality procedures and inspected before shipment.
Our manufacturing partner is registered with the U.S. Food and Drug Administration and maintains quality management systems aligned with FDA requirements for device manufacturing.
Note: FDA establishment registration means the facility is listed with the FDA as required for device manufacturers; it does not constitute FDA approval or endorsement of any specific product.
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DISTRIBUTION & SALES
NovaCare Medical LLC serves as the exclusive authorized distributor of The NovaCare Anti-Choking Device in the United States. We import devices from the FDA-registered manufacturing facility and distribute them directly to consumers through our e-commerce platform.
All devices sold through novacareus.com are:
- Imported from the FDA-registered manufacturing facility
- Inspected for quality and compliance before distribution
- Labeled in accordance with FDA requirements
- Supported by our customer service team in the United States
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INTENDED USE
The NovaCare Anti-Choking Device is intended for use as an airway suction device to assist in the removal of foreign objects causing upper airway obstruction. It is designed for use by caregivers, family members, and individuals in emergency choking situations.
This device is not a substitute for:
- Proper first aid training or CPR certification
- Emergency medical services (always call 911)
- The Heimlich maneuver or other established choking rescue techniques
- Professional medical evaluation and treatment
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REGULATORY COMPLIANCE
NovaCare Medical LLC is committed to maintaining full compliance with all applicable federal regulations governing the distribution and marketing of medical devices, including:
- Federal Food, Drug, and Cosmetic Act (FD&C Act)
- FDA regulations under 21 CFR (Code of Federal Regulations)
- Medical Device Reporting (MDR) requirements
- Advertising and promotion guidelines for medical devices
ADVERSE EVENT REPORTING: If you experience any adverse events or have safety concerns related to The NovaCare Anti-Choking Device, please report them to NovaCare Medical LLC at support@novacareus.com. You may also report directly to the FDA through MedWatch at 1-800-FDA-1088 or www.fda.gov/medwatch.
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QUESTIONS OR CONCERNS
For questions about our regulatory compliance, manufacturing standards, or device registration, please contact:
NovaCare Medical LLC
Email: support@novacareus.com
Location: Stamford, Connecticut, United States
🇩🇪 German Engineered · 🇺🇸 Made in the USA
The NovaCare anti-choking device is engineered in Germany and manufactured in the United States.