INNOVATIONS FOR ACCESS, INC.

FDA Device Registration & Listing · Hillsboro, OR, US · Registration 3004202080

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004202080
FEI Number
1000126788
Entity Name
INNOVATIONS FOR ACCESS, INC.
City/State/Country
Hillsboro, OR, US
Establishment Address
8531 NE Cornell Rd, STE 800,, Hillsboro, OR 97124, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
INNOVATIONS FOR ACCESS, INC. (Owner Number: 9058740)
Owner / Operator Contact Address
515 NW SALTZMAN ROAD #797, --, Portland, OR 97229, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K081740
PMA Number
N/A

All Registered Proprietary Names

HemoBand HB-1M HemoBand HB-NSXL HemoBand HB-NS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KOC Accessories, Blood Circuit, Hemodialysis Gastroenterology, Urology Class 2 876.5820 2008-04-23
KOC Accessories, Blood Circuit, Hemodialysis Gastroenterology, Urology Class 2 876.5820 2020-09-10

Official Correspondent

HAL OIEN, DMD, MAGD

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

INNOVATIONS FOR ACCESS, 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 3004202080. Last updated year: 2026. Please use registration number 3004202080 when referencing this establishment in official correspondence.
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