Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1051550

FEI Number

1051550

Entity Name

DEROYAL INDUSTRIES, INC.

City/State/Country

MAYNARDVILLE, TN, US

Establishment Address

165 RICHARDSON WAY, MAYNARDVILLE, TN 37807, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

DEROYAL INDUSTRIES, INC. (Owner Number: 1044833)

Owner / Operator Contact Address

200 DEBUSK LN., --, Powell, TN 37849, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Instrument, Surgical, Disposable - DeRoyal Support, Patient Position - DeRoyal Cushion, Wheelchair - DeRoyal Splint, Traction - DeRoyal Stax

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2001-02-21
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2005-08-08
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	1999-05-21
HSP	Splint, Traction	Orthopedic	Class 1	888.5890	1997-01-13

Official Correspondent

Elizabeth Reed

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DEROYAL INDUSTRIES, INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008583452	DeRoyal Industries, Inc.	Powell, TN, US
1057404	DeRoyal Industries, Inc.	POWELL, TN, US
1034876	DEROYAL INDUSTRIES, INC.	MAYNARDVILLE, TN, US
3021190810	DePre, LLC	Powell, TN, US
1055236	DEROYAL INDUSTRIES, INC.	NEW TAZEWELL, TN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K831798	I M, Inc.	DISPOSABLE SCALPELS	1983-07-19

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1051550. Last updated year: 2026. Please use registration number 1051550 when referencing this establishment in official correspondence.