Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010371670

FEI Number

3010371670

Entity Name

DELA DE MEXICO S DE RL DE CV

City/State/Country

TIJUANA Baja California, MX

Establishment Address

VALLE DE LOS CIRIOS 495 ABC, VALLE BONITO, TIJUANA Baja California 22250, MX

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Dela Incorporated (Owner Number: 10039726)

Owner / Operator Contact Address

175 Ward Hill Avenue, Ward Hill, MA 01835, 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
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2017-01-04
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2025-03-06
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2012-09-21
HSQ	Belt, Pelvic, Traction	Orthopedic	Class 1	888.5890	2012-09-21
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	2014-02-24
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2014-07-14
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2015-11-10
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2014-01-28

Official Correspondent

Peter Pherson

US Agent Details

Nesby Ovalle Business: Nesby Email: novalle@Delaquality.com Phone: (978) 7719041

Related Public Records

Same Entity

Dela Incorporated

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3000297887	DELA INCORPORATED	Ward Hill, MA, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

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2184046	OSBORN MEDICAL CORPORATION	CENTENNIAL, CO, US
3006979871	TRULIFE, LTD.	S. Yorkshire Sheffield, GB
3006137579	ALIGNMED INC.	Irvine, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010371670. Last updated year: 2026. Please use registration number 3010371670 when referencing this establishment in official correspondence.