FDA Registration & Regulatory Information | Guardian 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: Weyln Medical LLC
Location: Stamford, Connecticut, United States
Role: Authorized distributor of The Guardian Anti-Choking Device
Contact: Guardianspromise@gmail.com
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FDA DEVICE REGISTRATION
The Guardian 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: 868.6810
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
The Guardian Anti-Choking Device is manufactured by Yiwu Daqida Plastic Products Co., Ltd., an FDA-registered manufacturing facility.
Manufacturer: Yiwu Daqida Plastic Products Co., Ltd.
Location: Yiwu, Zhejiang Province, China
FDA Registration: Establishment #3029917416
Operation: Foreign Exporter, Manufacturer
This facility is registered with the U.S. Food and Drug Administration and complies with applicable FDA regulations for medical device manufacturing. All devices are manufactured in accordance with FDA quality system requirements.
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DISTRIBUTION & SALES
Weyln Medical LLC serves as the exclusive authorized distributor of The Guardian 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 guardiandevice.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 Guardian 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
Weyln 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 Guardian Anti-Choking Device, please report them to Weyln Medical LLC at Guardianspromise@gmail.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:
Weyln Medical LLC
Email: support@guardiandevice.com
Location: Stamford, Connecticut, United States