Certifications & Quality Standards
Certification documentation for procurement, professional approval and institutional integration. All certificates independently issued — not self-declared.
Hydrogen Wellness™ products are manufactured within established quality management environments and supported by internationally recognised manufacturing, engineering and product-quality standards.
Our commitment is to quality, consistency, traceability and customer confidence.
ISO 13485 Quality Management System
Selected Hydrogen Wellness™ products are manufactured within facilities operating quality management systems certified to ISO 13485.
ISO 13485 is an internationally recognised quality management standard commonly used within regulated manufacturing environments.
This certification relates to manufacturing quality systems and processes.
Important disclaimer
ISO 13485 certification does not mean a Hydrogen Wellness™ product is approved as a medical device in any specific jurisdiction.
Premium PEM Technology
Hydrogen Wellness™ systems utilise Proton Exchange Membrane (PEM) electrolysis technology designed for purity, consistency and operational reliability.
Where applicable, premium membrane configurations and long-life component architectures are available depending on product model and configuration.
Quality-Controlled Manufacturing
Products are assembled within documented quality-control processes and undergo inspection prior to shipment.
Our focus is consistency, reliability and long-term operational performance.
Global Market Experience
Products manufactured by our supply partners are distributed into multiple international markets.
Hydrogen Wellness™ supports customers globally through direct distribution and regional delivery networks.
FCC Part 15 Subpart B — Electromagnetic Compliance
Documentation
- Test report number:
- LST250598095FR
- Certificate number:
- LST250598095F
- Testing laboratory:
- Shenzhen LST Technology Co., Ltd.
- Accredited independent test lab · Bao'an District, Shenzhen, China
Test parameters & results
- Test standards:
- FCC Part 15 Subpart B · ANSI C63.4:2014
- Test date:
- May 22–30, 2025
- Test voltage:
- AC 120V (US voltage specification)
- Conducted emission test:
- PASS
- Radiated emission test:
- PASS
- Overall result:
- PASS
Models covered
QY-A900 · QY-A1200 · QY-A1800 · QY-A3000 · QY-F6000 · QY-F8400 · WZ-1
What FCC Part 15 Subpart B means
FCC Part 15 Subpart B covers electromagnetic emission limits for unintentional radiators — electronic devices that do not intentionally transmit radio frequency signals. This is the correct FCC compliance pathway for hydrogen generation equipment. Testing was conducted at US 120V specification in a fully equipped anechoic chamber using calibrated Rohde & Schwarz and Agilent test instruments. Both conducted and radiated emission tests passed all FCC Part 15 Class B limits.
Anechoic chamber test photographs
The following photographs are taken from the official FCC test report (LST250598095FR) and show the machine being tested under radiated emission conditions in a fully equipped RF-shielded anechoic chamber.
FCC certification — why it matters for European and German buyers.
Understanding Our Quality Commitments
These certifications and quality standards relate to:
- Manufacturing quality systems
- Production processes
- Quality control
- Product consistency
- Traceability
- Supplier quality management
They do not constitute:
- Medical device approval
- Therapeutic approval
- FDA clearance
- TGA approval
- Disease-treatment claims
- unless expressly stated for a specific product and jurisdiction
Certification marks
Conformité Européenne mark indicating the product meets EU health, safety and environmental protection requirements for sale within the European Economic Area.
Federal Communications Commission certification confirming the device complies with US electromagnetic interference standards for unintentional radiators.
Restriction of Hazardous Substances directive limiting the use of specific hazardous materials in electrical and electronic equipment.
International standard for quality management systems, ensuring consistent product quality and continuous improvement in manufacturing processes.
Quality management standard for the design and manufacture of medical devices, ensuring regulatory compliance and risk management in production environments.
Marks as applied to product
Documentation available on request.
Full certification documentation — including certificates, issuing bodies, applicable standards, and validity dates — is available to professional operators, institutional procurement teams, and verified professional buyers.
Documentation is provided under standard commercial confidentiality terms within 2 business days of request.
Quality you can verify.Confidence in every detail.
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