Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020879941

FEI Number

3020879941

Entity Name

ABLE SOLUTIONS. INC

City/State/Country

Harrisonburg, VA, US

Establishment Address

801 Friendship Dr, Harrisonburg, VA 22802, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Able Solutions. INC (Owner Number: 10090002)

Owner / Operator Contact Address

801 Friendship Dr, Harrisonburg, VA 22802, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PQE	Ostomy Care Kit	Gastroenterology, Urology	Class 1	876.5900	2024-01-31
OHR	Catheter Care Tray	Gastroenterology, Urology	Class 2	876.5130	2024-04-10

Official Correspondent

Elizabeth Otto

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Able 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 3020879941. Last updated year: 2026. Please use registration number 3020879941 when referencing this establishment in official correspondence.