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OEM · ODM · Turnkey Manufacturing

ISO 13485-Certified Medical Device & Health Appliance OEM/ODM — Made in Taiwan Since 1996

From product design to turnkey delivery, we are the OEM/ODM contract manufacturer behind leading health brands across the US, Europe, and Japan.

ISO 9001ISO 13485CEFCCRoHSPSE
Quality & Compliance

Certified for the Markets You Sell In

Every certificate is verifiable — scans available on request.

ISO 13485:2016 certificate of registration — Gooten Innolife Corporation ISO 13485:2016
CE marking CE
FCC compliance mark FCC
PSE mark (Japan) PSE
ETL listed mark (Intertek) ETL
VDE certification mark VDE
What We Build

Three Things We Do Exceptionally Well

Medical device assembly and testing on the production line

Medical Device OEM

Medical device contract manufacturing under an ISO 13485 quality system — dedicated assembly lines and documentation support for FDA-cleared home-use devices.

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Health appliance units on the assembly line

Health & Wellness Appliances ODM

In-house R&D for air purification, water filtration, UV-C sanitizing, and baby-care devices — engineered and private-label ready for your brand.

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PCB/PCBA assembly — circuit board with SMT components

Consumer Electronics

PCB/PCBA design, SMT assembly, battery and power management — full electronics integration under one roof.

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30Years of Manufacturing
— since 1996
950K+Units Shipped Globally
50+Countries Served
18+Years — Longest Active
Client Partnership
From OEM to Co-Developer

Their First Device Was Built Here.
So Were the Next Three Generations.

In 2008, a leading U.S. hair-growth device brand chose us to manufacture their first home-use device. Eighteen years later, we co-develop their next generations — from industrial design and engineering to certification and turnkey delivery.
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18+ years of partnership timeline: 2008 first device, 2014 engineering, 2019 certified quality, today co-developer
Track Record

Trusted by Brands in the US, Europe & Japan

US hair-growth device leaderPartner since 2008 — four product generations
US photomedicine device developerClinical & home-use light-therapy systems, built in Taiwan
Your brand could be nextStart with a quote →
How We Work

From Idea to Shipment, One Accountable Partner

Consult

NDA signed, with a prompt engineering reply.

Quote & DFM

Quotation with design-for-manufacturing review.

Sample

Tooling and T1 samples.

Validate

Certification support and pilot run.

Ship

Mass production and global delivery.

Come See the Factory Yourself

The fastest way to evaluate a manufacturing partner is to walk the floor. We host brand teams from the US, Europe, and Japan — book a tour, or start with a quote.

Book a Factory Tour
Start a Conversation

Request a Quote

Tell us what you're building. An engineer — not a sales bot — will get back to you.

  • NDA available before any technical discussion
  • Design-for-manufacturing feedback with every quotation
  • English-speaking engineering team
Your information stays confidential. We never share project details.