Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1059079

FEI Number

1000525333

Entity Name

THE SOULE CO

City/State/Country

LUTZ, FL, US

Establishment Address

26543 Wild Fern Cir., LUTZ, FL 33559, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

THE SOULE CO., INC. (Owner Number: 9020536)

Owner / Operator Contact Address

4322 PET LN., --, Lutz, FL 33559, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BEDDING, DISPOSABLE, MEDICAL ORTHOSIS, LIMB BRACE SUPPORT, PATIENT POSITION SPLINT, HAND, AND COMPONENTS Board, arm (with cover), non-sterile seat Cushion (non flotation)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2008-05-15
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2008-06-03
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2008-05-15
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2008-05-15
NOD	Board, Arm (With Cover), Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2008-05-15
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2008-05-15

Official Correspondent

Lindsey Osborne

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

THE SOULE CO., INC.

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3011189534	DS TEXTILE PRODUCTS, INC.	Gulf Shores, AL, US
3040278131	Ozuufuk Tekstil Ith. Ihr. San. Ve Tic. Ltd. Sti	Istanbul, TR
3013682767	SAVE MY FACE, INC.	Valencia, CA, US
3016752930	ZEN LINEN INTERNATIONAL PRIVATE LIMITED.	Chennai Tamil Nadu, IN
3043051417	SUNING JUNQI MEDICAL HYGIENE PRODUCTS (CAMBODIA) CO., LTD.	Kampong Soam Preah Sihanouk, KH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1059079. Last updated year: 2026. Please use registration number 1059079 when referencing this establishment in official correspondence.