United States · FDA
SUNGO supports medical device manufacturers with 510(k) submissions, testing plans, US Agent services, establishment registration, device listing and FDA inspection preparation.
Project counts as of 30 June 2026. Services are tailored to the device and project scope; past experience does not guarantee clearance.
Why SUNGO
Our laboratory and regulatory teams have worked together on sterilization indicator tape and sterilization pouch 510(k) projects, connecting test planning and execution with submission documentation and responses to FDA questions.
Support covers gap assessments, predicate device selection, submission preparation and responses to additional information requests. We review existing documentation with you to identify the work your device needs.
Our US team provides US Agent services and local communication support, working with colleagues on establishment registration, device listing and annual maintenance.
Consulting addresses quality-system documentation, inspection preparation, remediation of findings and follow-up responses, with attention to records and day-to-day practices. Project counts are as of 30 June 2026.
Service scope
Choose individual services or a coordinated project based on your device and existing documentation.
Review intended use, device characteristics and the applicable submission route.
Review available documentation and identify gaps against the proposed submission.
Confirm relevant standards and performance, safety and biocompatibility testing needs.
Prepare, organize and submit the 510(k) documentation.
Help analyze and respond to requests for additional information.
US Agent services through the SUNGO US team.
Assist with establishment registration and device listing.
Support annual renewal payments and registration information updates.
Quality-system consulting tailored to the manufacturer.
Prepare for FDA inspections and address compliance findings.
Review device labeling, UDI information and promotional claims.
Working with SUNGO
The sequence is tailored to your project. Some activities may run in parallel.
Review the product code, intended use and submission basis.
Identify suitable predicate devices and technical differences requiring evidence.
Define applicable performance, biocompatibility, electrical safety, EMC and software work.
Compile technical documentation, labeling and test evidence.
Coordinate explanations, supporting documents and any additional testing.
Support registration, listing, US Agent arrangements and annual updates.
Product experience
Bruxism guards, breast pumps, wheelchairs and gowns are research topics based on public documents; the research samples are not presented as SUNGO client projects. Indicator tape and pouch experience includes client projects.
Research on prescription and OTC routes, materials, predicate selection and performance testing.
Research on home-use conditions, electrical safety, EMC, batteries and biocompatibility.
Research on performance testing, battery systems, stability and braking.
Research on barrier performance, seam strength and linting.
Client project experience involving indicator performance, stability and sterilization-related testing.
Client project experience involving aging, packaging performance and relevant validation work.
Client project experience
SUNGO has helped clients obtain 510(k) clearance for sterilization indicator tape and sterilization pouches. Laboratory and regulatory personnel worked together on testing plans, applicable performance, aging, sterilization and biological evaluation work, submission preparation and review correspondence. Contact us to discuss experience relevant to your product.
Support applicable establishment registration and device listing, initial records and annual updates. Reconcile establishment activities, product codes and premarket requirements.
Coordinate US agent arrangements and contact details for foreign manufacturers. Clarify regulatory communication duties; an agent appointment is not marketing authorisation.
Coordinate applicable identification and database information, reconcile models and labelling, and plan maintenance when submitted information changes.
Assess certification against manufacturing and shipment routes and US marketing status. CFG-NE concerns eligible devices manufactured outside the US and shipped between foreign countries; it does not replace required 510(k) clearance.
FDA registration and listing do not mean approval, clearance or authorisation. FDA does not issue medical-device registration certificates. Food and cosmetics use separate regulatory frameworks and need separate assessment.
Specific requirements are subject to product assessment and the competent authority’s current regulations.
Free initial consultation
Email the product name and instructions for use. Our team will respond within one business day to discuss the next steps.