| 1 | General-purpose red and near-infrared belt | Red: 630–660 nm NIR: 810–850 nm | LED-based device; independently measured irradiance and dose controls; timer, automatic shutoff, insulated wiring, and skin-contact materials suitable for the intended use. | IEC 60601-1 for medical electrical safety, IEC 60601-1-2 for electromagnetic compatibility, IEC 62471 for photobiological safety, ISO 14971 for risk management, and ISO 10993 where prolonged skin contact is claimed. | The route depends on intended purpose and promotional claims. A general wellness product may be treated differently from a device making therapeutic or disease claims. | EU: MDR assessment may apply for medical claims. United States: FDA requirements depend on product classification and claims. Other markets may require local registration or importer representation. | Test reports, wavelength and irradiance report, electrical safety report, EMC report, biocompatibility rationale, risk-management file summary, labeling, and user instructions. |
| 2 | Low-heat flexible belt for sensitive users | Red: 630–660 nm Optional NIR: 810–830 nm | Low-temperature operation with continuous temperature monitoring, soft encapsulation, rounded edges, adjustable fastening, and a clearly stated maximum session duration. | IEC 60601-1, IEC 60601-1-2, IEC 62471, ISO 14971, and relevant material safety evaluation under ISO 10993 when the belt contacts skin. | No single international “red-light belt certificate” exists. Compliance must be demonstrated against applicable electrical, optical, material, and market-specific rules. | Buyers should verify mains adapters, plugs, battery cells, chargers, and labeling separately because these components may be subject to additional national requirements. | Thermal test data, battery and charger reports, optical safety assessment, materials declaration, cleaning instructions, and overheating protection test. |
| 3 | Battery-powered travel belt | Red: red 630–660 nm NIR: 810–850 nm | Rechargeable battery, protected charging circuit, transport-safe battery pack, USB or certified external power supply, battery state indicator, and automatic session cutoff. | IEC 60601-1 and IEC 60601-1-2 where applicable; IEC 62133-2 for rechargeable lithium battery safety; UN 38.3 transport testing for lithium battery shipping. | Battery transport compliance is separate from medical-device or wellness-product compliance. The complete belt and the battery pack require separate verification. | International shipments commonly require UN 38.3 evidence and appropriate dangerous-goods documentation. EU sales may also involve battery and waste obligations. | UN 38.3 test summary, IEC 62133-2 report, battery SDS where required, charger specifications, EMC report, and shipping classification. |
| 4 | EU-focused therapeutic-claim belt | Red: 630–660 nm NIR: 810–850 nm | Controlled output, traceable calibration, defined intended purpose, clinical evaluation proportional to claims, post-market monitoring, and multilingual instructions. | IEC 60601-1, IEC 60601-1-2, IEC 62471, ISO 14971, ISO 13485 quality management, and ISO 10993 where applicable. | Medical claims may bring the product within Regulation (EU) 2017/745 (MDR). Classification depends on intended purpose, mode of action, and risk profile. CE marking is not a substitute for technical documentation. | EU economic-operator obligations, technical documentation, clinical evaluation, declaration of conformity, labeling, UDI obligations where applicable, and authorized-representative requirements for certain non-EU manufacturers. | EU declaration of conformity, technical-file summary, clinical evaluation evidence, ISO 13485 certificate, risk file, PMS plan, and CE/UDI information where applicable. |
| 5 | United States wellness-oriented belt | Red: 630–660 nm NIR: optional | Conservative wellness wording, measurable optical output, timer control, electrical safety evaluation, clear contraindications, and no unsupported disease-treatment claims. | IEC 60601-1, IEC 60601-1-2, IEC 62471, and applicable FCC equipment authorization requirements for electronic emissions. | FDA obligations depend on intended use and claims. A product marketed to diagnose, cure, mitigate, treat, or prevent disease may be regulated as a medical device; a wellness claim does not automatically guarantee exemption. | Check FDA establishment, listing, premarket, labeling, and reporting requirements as applicable. Wireless versions may require additional FCC review. | FDA classification rationale, labeling and claims review, electrical and EMC reports, optical safety report, complaint procedure, and wireless authorization documents if applicable. |
| 6 | UK-focused post-Brexit belt | Red: 630–660 nm NIR: 810–850 nm | Defined intended purpose, traceable production controls, optical and thermal limits, English labeling, and a documented adverse-event and complaint process. | IEC 60601-1, IEC 60601-1-2, IEC 62471, ISO 14971, ISO 13485, and ISO 10993 where relevant to skin contact. | Medical-device placement on the Great Britain market may require UKCA or accepted CE routes during applicable transition arrangements. Northern Ireland has separate EU-related rules in relevant cases. | Verify MHRA registration, UK responsible-person obligations for overseas manufacturers, labeling, and the current recognition period for CE marking. | UK declaration and conformity evidence, MHRA registration information where applicable, responsible-person details, risk file, and post-market surveillance records. |
| 7 | Canada and Australia distribution belt | Red: 630–660 nm NIR: optional 810–850 nm | Stable output over the stated service life, documented labeling claims, compliant power supply, skin-contact assessment, and a defined maintenance procedure. | IEC 60601-1, IEC 60601-1-2, IEC 62471, ISO 14971, and ISO 13485 where a regulated medical-device quality system is required. | Canada may require a Health Canada medical-device licence depending on classification. Australia may require inclusion in the ARTG for regulated medical-device supply. | Verify Canadian device licensing and importer obligations separately from Australian TGA/ARTG requirements; local classification is claim-dependent. | Classification rationale, local licence or ARTG evidence where applicable, quality certificate, electrical and optical test reports, English labeling, and importer documentation. |
| 8 | Japan and South Korea import belt | Red: 630–660 nm NIR: 810–850 nm | Output verification in both operating and charging modes, localized warnings, translated instructions, compliant plug or adapter, and documented product traceability. | IEC 60601-1, IEC 60601-1-2, IEC 62471, ISO 14971, and applicable national deviations or local testing requirements. | Medical claims may trigger approval or notification under the applicable Japanese or Korean medical-device framework. Classification and route vary by intended use. | Japanese importers and local-language labeling may be required. South Korean MFDS requirements, local representation, and product classification should be confirmed before import. | Local-language instructions, country-specific conformity documents, importer details, test reports, risk analysis, and evidence supporting translated claims. |
| 9 | China and Southeast Asia marketplace belt | Red: 630–660 nm NIR: optional 810–850 nm | Consistent LED binning, production-line optical testing, overheating protection, compliant adapter, local-language warnings, and serial or batch traceability. | IEC 60601-1, IEC 60601-1-2, IEC 62471, ISO 14971, and applicable national standards or deviations in the destination market. | China medical-device registration or filing may be required when medical claims are made. Southeast Asian requirements differ by country and may involve local establishment or importer obligations. | Confirm NMPA requirements for China and the current medical-device rules of each Southeast Asian destination; marketplace listing alone is not proof of compliance. | NMPA or local registration evidence where applicable, Chinese or local-language labeling, factory quality records, optical test reports, and importer details. |
| 10 | Professional-use belt with advanced controls | Red: 630–660 nm NIR: 810–850 nm Programmable dose | Programmable treatment sessions, password-protected settings where appropriate, calibration records, temperature monitoring, fault detection, service intervals, and controlled software updates. | IEC 60601-1, IEC 60601-1-2, IEC 62471, ISO 14971, ISO 13485, ISO 10993 where applicable, and IEC 62304 if software is part of the medical-device function. | Software, programmable controls, and professional therapeutic claims can increase regulatory scrutiny. The applicable route must be determined from the final intended purpose and system architecture. | Buyers should assess cybersecurity, software lifecycle, data protection, servicing, calibration, and professional-user training obligations in every target market. | Software lifecycle documentation, cybersecurity risk assessment, calibration certificates, service manual, fault logs, usability evidence, and complete technical documentation. |