Quality & Compliance You Can Rely On
Built for Global Oral Care
Quality Is Designed In: Not Inspected In
You don’t want quality problems discovered at the end of production. You want them prevented from the very beginning.
At TLUCKY, quality management starts at product design, component selection, and process planning, long before mass production begins. Every water flosser is developed, tested, and manufactured under a structured quality system that supports stable performance, regulatory compliance, and consistent delivery.
Certified Quality Management Systems
To help you reduce compliance risks and accelerate market entry, TLUCKY operates under internationally recognized quality management systems:
- ISO 9001:2015 – Quality Management System
- ISO 13485:2016 – Medical Device Quality Management
- FDA Registered – U.S. market compliance support
- Products compliant with CE, FCC, CB, ETL requirements
These certifications are not just labels — they are embedded into your product’s full lifecycle, from R&D validation to final shipment.
Performance Validation You Can Trust
Your customers expect consistent performance, not lab-only promises.
TLUCKY validates water flosser performance through systematic testing, including:
- Long-term durability and aging tests
- Water leakage prevention verification
- Noise control under load conditions
- Stable pulse frequency and pressure output
- High and low temperature operation tests
Our patented composite pump technology has passed extended aging tests up to 1095 days (5 minutes a day) without leakage, helping you deliver products that perform reliably over time.
Structured Quality Control at Every Stage
You benefit from a multi-layer quality control framework designed to protect your brand reputation and reduce after-sales risk. We conduct a 27-step QC process from raw materials procurement to pre-shipment inspections. We also establish a DQA (Development Quality Assurance) and product Laboratory to control product design quality and reliability from the product development stage.
Incoming Quality Control (IQC)
- Supplier qualification and evaluation
- Critical components inspection
- Material traceability management
In-Process Quality Control (IPQC)
- Standardized operating procedures
- Key process checkpoints
- Functional and performance monitoring
Final Quality Control (FQC)
- Appearance inspection
- Electrical safety testing
- Water pressure & pulse frequency verification
- Packaging integrity checks
Partner with Water Flosser Certified by FDA, CE, and FCC
When your products are intended for multiple international markets, compliance and manufacturing credibility should never be a barrier. TLUCKY certified quality systems and proven production capabilities help you enter and serve global markets with confidence.
