Hydrosense
Product Safety & Compliance
- Board Certified Compliance Officer
- PDMS is Biocompatible
- 3M Adhesive is non Hypoallergenic and is skin friendly
- 3M 1577 adhesive is dermatologically tested and proven to prevent skin irritation, ISO Closed Patch Sensitization, etc.
- GDPR Compliant
- Sweat sensor technology is non-invasive and does not breach the skin.
- SDS - For all raw materials Checked
- No harmful chemicals or reactive agents in the sensor
- Used eco-friendly materials in product design and packaging.
- Incorporated recyclable components to minimize environmental impact.
- Followed sustainable manufacturing practices in line with UN SDGs.
- Designed in Sweden, Manufactured in India
Introduction
This document outlines the policies governing the design, manufacturing, usage, and maintenance of the sports sweat hydration sensor, a consumer wearable product. As the product is classified as a non-medical wellness device, it does not require FDA or CE certifications. These policies ensure product safety, user privacy, regulatory compliance, and environmental sustainability.
Product Classification
The sports sweat hydration sensor is categorized as a consumer health and fitness wearable designed to monitor hydration levels, sweat rate, and electrolyte loss during physical activity. It is not intended to diagnose, treat, cure, or prevent any medical condition. Key Statement: The device is intended for wellness purposes only and does not replace professional medical advice or clinical assessments.
Safety and Risk Management
Biocompatibility: All materials in contact with the skin meet ISO 10993 biocompatibility standards to minimize risks of irritation or allergic reactions. Risk Assessment: Comprehensive Failure Mode and Effects Analysis (FMEA) is conducted during the product development phase. Regular testing is performed to ensure reliability, accuracy, and durability of the device under normal usage conditions.
Regulatory and Legal Compliance
Exemption from Medical Certification: The product is certified as a wellness device by regulatory consultants, affirming that it does not fall under the scope of medical device regulations. Chemical Safety: All materials comply with REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals). Product Labelling: The product packaging and user manual explicitly state: ‘This device is for wellness and fitness tracking purposes only.’ ‘Not intended for medical use or clinical diagnostics.’
Data Privacy and Security
Data Collection and Usage: The device collects non-sensitive user data related to hydration and sweat analytics. User consent is mandatory before data collection, storage, or sharing, in compliance with GDPR (General Data Protection Regulation) for the EU market. Security Measures: Data is encrypted during transmission and storage using industry-standard protocols (e.g., AES-256 encryption). The accompanying app follows OWASP Mobile Security Guidelines to safeguard user data.
User Guidelines and Disclaimers
Usage Instructions: Users must follow the provided instructions for proper sensor application, data tracking, and app usage. The device should not be used on damaged or broken skin. Disclaimer: The product is not a substitute for professional medical advice. The device should not be used for diagnosing dehydration-related medical conditions or managing critical electrolyte imbalances.
Environmental and Sustainability Policies
Eco-Friendly Design: The device uses recyclable packaging materials. Components are designed to minimize environmental impact through eco-friendly material selection and reduced e-waste. Recycling and Disposal: Users are encouraged to recycle the device through authorized e-waste disposal programs.
Intellectual Property and Licensing
All technologies, designs, and trademarks associated with the product are protected under intellectual property laws. Unauthorized reproduction or distribution of the product or its technologies is prohibited.
Customer Support and Feedback
Support Channels: Customers can contact support via email, phone, or the mobile app for assistance with technical issues or troubleshooting. Feedback Integration: User feedback is actively collected to improve future product iterations.
Testing and Validation
Performance Validation: The device undergoes rigorous testing for accuracy, durability, and reliability under simulated athletic conditions. Third-Party Validation: Independent laboratories validate the sensor’s performance for measuring hydration levels, sweat rate, and electrolyte loss.
App and Firmware Policies
The mobile app accompanying the device undergoes regular updates to enhance features and fix bugs. Compatibility with major operating systems (iOS, Android) is ensured.