Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013586954

FEI Number

3013586954

Entity Name

NPI SOLUTIONS INC.

City/State/Country

Morgan Hill, CA, US

Establishment Address

685 Jarvis Drive, Morgan Hill, CA 95037, US

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device for Another Party (Contract Manufacturer),Reprocess Single-Use Device,Manufacture Medical Device,Repack or Relabel Medical Device

Owner / Operator

NPI Solutions Inc. (Owner Number: 10059967)

Owner / Operator Contact Address

685 Jarvis Drive, Morgan Hill, CA 95037, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K173358

PMA Number

N/A

All Registered Proprietary Names

ONA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ONA	Computer Assisted Hair Harvesting System	Neurology	Class 2	882.4560	2019-03-15

Official Correspondent

Tri Niven

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NPI Solutions Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013586954. Last updated year: 2026. Please use registration number 3013586954 when referencing this establishment in official correspondence.