Short · tall · pneumatic · standard
Walking boots
Protective shell architecture, liner systems, uprights, closures and sizing options for post-injury and post-operative support programs.
52036 · 52002 · 52004 · 52017 · 52006
Fabricación de soportes ortopédicos · Desde 2016
Capacidad para programas ortopédicos exigentes.
Una operación de más de 4.000 m² en Xiamen, una plataforma de 65 modelos y un sistema de calidad documentado para marca propia, distribución y compras institucionales.
2016Established
4,000+ m²Approx. manufacturing footprint
15k–23kIndicative units / month
7–10 daysIndicative sample lead time
Vías comerciales
Empecemos por su forma de llegar al mercado.
Definimos producto, documentación y entrega según su canal y sus requisitos.
Private label & OEM / ODM
Existing-model sourcing, brand application, color direction, retail packaging, inserts and product documentation.
Distribution & wholesale
A category-led range for distributors, retailers, clinics and marketplace operators planning repeat supply.
Institutional sourcing
Specification matching, sample comparison, quality documentation and tiered-volume planning for structured RFQs.
Arquitectura de producto
Una base de fabricación. Un portafolio ortopédico conectado.
Lance una categoría o combine modelos compatibles en un programa más amplio.
ROM · hinged · stabilizing · immobilizing
Knee bracing
A broad knee platform spanning adjustable range-of-motion structures, rigid stabilization and everyday support formats.
42001 · 42003 · 42007 · 42010 · 42012 · 42019
Ankle · back · shoulder · elbow · wrist
Upper body & soft supports
Sewn and structured supports that extend a program beyond knee and walker categories while sharing materials, packaging and documentation workflows.
52069 · 60241 · 22006 · 22039 · 72020 · 83010
Capacidad de fabricación
Un sistema de producción que el comprador puede examinar.
Materiales, costura, montaje, inspección, etiquetado y expedición forman un flujo trazable.
Indicative planning capacity of 15,000–23,000 units per month across soft-goods product families.
Final output depends on SKU mix, forecast, automation and production schedule.
30–45 days
Indicative standard production lead time after final approvals.
500 EA
Common planning MOQ for many standard models; confirmed by SKU.
OEM / ODM
Product selection, brand application, packaging and scoped development.
Calidad y documentación
Las credenciales forman un sistema, no una decoración.
Mostramos el marco de calidad y facilitamos copias controladas y correspondencia por modelo para proyectos cualificados.
Representative brand visual. Original documents are not published on this page; controlled copies are available for qualified review.
ISO 13485:2016
Certificate 117 26 MD 0100 R0 00
Quality-management system certificate stated as valid from 8 June 2026 through 7 June 2029.
FDA establishment registration
FY2026 registration 3031170295
Establishment registration and device listings for stated support families. Registration and listing do not mean FDA approval or endorsement.
EU MDR Class I documentation
Applicable product families
Declaration of Conformity documentation is mapped to the relevant model and destination-market scope during project review.
ISO 10993-23:2021 testing
Report SSMT-R-2025-17620-01B
Skin-irritation test documentation available within the controlled product and material review package.
Document relevance is confirmed by legal entity, product model, material, labeling, intended market and current validity.
Review the quality-document framework →Ejecución del programa
Del briefing al suministro recurrente.
- 01
Commercial brief
Target market, channel, product family, forecast and intended cooperation model.
- 02
Model matching
Existing SKU review, specification comparison and benchmark-sample assessment.
- 03
Sample validation
Indicative 7–10 business days after model and sample requirements are confirmed.
- 04
Brand & documentation
Artwork, packaging, labeling, manuals, market documents and quality plan.
- 05
Production release
Final specification, purchase order, inspection criteria and shipment plan.
- 06
Repeat supply
Forecast review, product-family planning and corrective-action support when required.
Preguntas de compradores
Los datos prácticos, desde el principio.
What is the typical MOQ?
Many standard-model quotations use 500 EA as an initial planning point. Final MOQ depends on SKU, size mix, packaging, branding and material requirements.
How long does production take?
Standard production is typically planned at 30–45 days after the specification, artwork and purchase order are approved. Shipping time is additional.
What can be customized?
Programs may include existing-model selection, logo placement, color direction, retail box, product card, package insert, size guidance and manual content.
Which documents are available?
The controlled review package may include company records, ISO 13485 certification, applicable EU MDR documentation, FDA establishment and listing information, test reports and product-level files.
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Comparta un mercado, un producto o una muestra de referencia.
Indique categoría, cantidad estimada, mercado, marca y documentos necesarios.