Certified · Audited · Tested in-house
Quality you can download, audit and test.
Two ISO certificates, a full amfori BSCI social audit and a reliability lab next to the production lines. Every claim on this page can be checked, and every batch we ship can be traced.
- Medical breast massagers
- ISO 13485
- Quality management
- ISO 9001
- Dedicated QC inspectors
- 20+
- In-house reliability tests
- 8
Independently certified. Independently audited.
Both management systems are certified by accredited bodies and audited every year. Download the certificates and check them with the issuer.
Four checkpoints between raw material and your carton.
More than 20 quality staff work across every floor. Problems are caught at the station where they start, not at final inspection.
- IQC
Incoming quality control
Every batch of silicone, motors, batteries, PCBs and packaging is checked before it reaches the line. Motors are tested for speed, current and noise on a dedicated micro-motor tester.
- PQC
In-process control
Inspectors patrol molding, spraying, soldering and assembly, checking first pieces and sampling through each shift against the approved golden sample.
- FQC
Final quality control
Finished units are checked for function, appearance, color and waterproof sealing before they are released to packing.
- OQC
Outgoing quality control
Packed goods are sampled against your AQL, with carton marks, labels and quantities verified. Your inspector is welcome at pre-shipment inspection.
We break it before your customers can.
New designs are tested before tooling is signed off, and production lots are sampled before they ship. Test records are shared with you as part of validation.
- T01
Plug & unplug
Charging-port insertion and withdrawal cycles, with insertion force measured on a horizontal force tester.
- T02
Button life
Automated key-press endurance on every switch design, counted per station.
- T03
Swing life
Cables and flexible joints bent back and forth until the design proves its fatigue limit.
- T04
Motor inspection
Speed, current and insulation checked on incoming motors against set upper and lower limits.
- T05
Salt spray
Corrosion resistance of charging contacts, weights and other metal parts.
- T06
Temperature & humidity
Climatic chamber cycling that simulates storage, shipping and bathroom conditions.
- T07
Drop test
Products and retail packs dropped from set heights onto a steel base.
- T08
Transport test
Vibration-table simulation of truck and sea freight for export cartons.
Certified in your name, for your markets.
Product certificates belong to the brand, so we don't sell you ours. We design to the standard from the first CAD model, prepare samples and technical files, and work with the accredited lab you choose, so the reports carry your brand and model number.
CE / UKCA
Technical files and samples for EU and UK markets
FCC
Radio and EMC testing for Bluetooth and electronic products
REACH · RoHS · Prop 65
Chemical and restricted-substance testing
EN 1400 · 16 CFR 1511
Pacifier standards for the EU and US
ISO 10993 · FDA 177.2600 · LFGB
Material data for skin-contact and food-contact LSR grades
UN38.3 · MSDS
Battery safety documents for air and sea freight
05 / Traceability
Every lot has a paper trail.
- Golden sampleA signed reference unit is kept for every approved product and used at every inspection.
- Material recordsSilicone grade and supplier batch are recorded for each production lot.
- Inspection reportsIQC, in-process and final inspection records are available on request.
- Lot codingCartons and, where required, units carry lot codes that link back to production records.
06 / Buyer questions
Quality, common questions.
Can't find what you need? Email elvis@leutoo.com and an engineer will reply within one working day.
Q01 Which certificates does your factory hold?
ISO 13485:2016 (SGS United Kingdom, CN25/00005740), covering the manufacture of medical breast massagers, and ISO 9001:2015 (Shanghai Sailway, SW25Q21479R0M), covering silicone electronic massagers including mother and baby products. We also passed a full amfori BSCI social audit by SGS in September 2025.
Q02 Can I verify your certificates?
Yes. Download the PDFs on this page and check the certificate numbers with SGS and Sailway, or through the IAF CertSearch database.
Q03 Do your products come with CE, FCC or EN 1400 certificates?
Product certificates are issued per product and per brand. We design to the standard from the start, supply samples and technical files, and testing is done at the accredited lab you choose, so the report carries your brand and model.
Q04 What AQL do you inspect to?
Outgoing inspection follows the AQL agreed in your order, commonly ANSI/ASQ Z1.4 (ISO 2859-1) General Inspection Level II. Critical functions such as waterproofing and charging are checked more tightly.
Q05 Can we send our own inspector or a third-party QC company?
Yes. Your team, SGS, QIMA, Bureau Veritas or any inspector you appoint is welcome at the factory for in-process or pre-shipment inspection.
07 / Request for quotation
Tell us what you're building.
An engineer, not a sales script, replies within one working day with questions, a feasibility view and next steps. Tick the NNN box and we'll send our signed NNN agreement before you share drawings.
- Emailelvis@leutoo.com
- Phone+86 158 1584 0058
- WhatsAppMessage us
RFQ received
Thank you. Your brief is with our engineering team.
We've emailed you a copy. Expect a reply from a Leutoo engineer within one working day (China time, GMT+8).