Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000626221

FEI Number

1000626221

Entity Name

PRIM,S.A.

City/State/Country

Mostoles Madrid (Province), ES

Establishment Address

Calle Yolanda Gonzalez, No. 15, Mostoles Madrid (Province) 28938, ES

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PRIM,S.A. (Owner Number: 9012483)

Owner / Operator Contact Address

POLIGONO INDUSTRIAL NO.1,, CALLE YOLANDA GONZALEZ (Antigua CALLE F.) NO. 15, MOSTOLES, ES-M 28938, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AQTIVO, Joint, Tight, External Brace AIRTEX MOTTIO, Joint, Elbow, External Brace AQTIVO, Joint, Elbow, External Brace PRIM CLUBAX AJUSTABLE ESSENTIAL HUMERUX AIRMED CLUBAX MOVIL MYPRIM KIDS HEMISAFE AQTIVO, Joint, Wrist, External Brace MYPRIM KIDS SPINAIR CONFORT PRIM Camp PRIM PRIMSPINE MYPRIM KIDS PRIMSPINE MAMMY AQTIVO PRIM MYPRIMKIDS AIRTEX PRIM MYPRIM KIDS MOTTIO AQTIVO PRIM PRIMSPINE CARE + CAMP XXI PRIMSPINE CARE

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	2019-02-08
ILE	Sling, Arm, Overhead Supported	Physical Medicine	Class 1	890.3475	2023-04-17
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2006-01-26
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	1995-02-21
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2023-04-17
QSB	Orthosis, Truncal, Pregnancy	Physical Medicine	Class 1	890.3490	2022-06-11
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	1998-11-20
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2019-02-08
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	1998-11-20

Official Correspondent

No official correspondent registered.

US Agent Details

Solmarie Velez Rivera Business: Business Excellence Consulting, Inc. Email: solmarie@calidadpr.com Phone: (787) 7057272

Related Public Records

Same Entity

PRIM,S.A.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005459839	PRIM, S.A.	Casarrubios del Monte Toledo, ES

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000626221. Last updated year: 2026. Please use registration number 1000626221 when referencing this establishment in official correspondence.