Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010328269

FEI Number

3010328269

Entity Name

PDI WORKS, LLC

City/State/Country

Cleveland, TN, US

Establishment Address

2150 S LEE HWY, Cleveland, TN 37311, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

PDI Works, LLC (Owner Number: 10044465)

Owner / Operator Contact Address

2150 South Lee Hwy, Cleveland, TN 37311, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K113037

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
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2013-06-15
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2013-06-15

Official Correspondent

Thu-Ha Duncan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PDI Works, LLC

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3003255790	WITKO INCORPORATED	Wolcott, IN, US
3038295706	JUST KEEP HEALTHY CO., LTD.	Samkkei Munichay District Kampong Speu, KH
3007731000	VGH SOLUTIONS INC	Markham Ontario, CA
3008048783	DRTV Asia LTD	Panyu GuangZhou Guangdong, CN
3008507279	CHOICEMMED AMERICA CORPORATION	Bristol, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010328269. Last updated year: 2026. Please use registration number 3010328269 when referencing this establishment in official correspondence.