Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005532347

FEI Number

3005532347

Entity Name

SPENCER ITALIA SRL

City/State/Country

Sala Baganza Parma, IT

Establishment Address

Via Provinciale, 12, Sala Baganza Parma 43038, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Spencer Italia srl (Owner Number: 10033882)

Owner / Operator Contact Address

Via Provinciale, 12, Sala Baganza, IT-PR 43038, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ST02018A RSP - PAEDIATR. SPID. STRAPS SYST. FOR SPINE BOARD ST02035L ROCK-STRAPS IMMOBILIZATION BELTS ADULT BACKBOARD/ROCK-STRAPS ST00497B DNA STRAP BELT W/INTEGRATED RE-WINDING SYSTEM ST02039A T-STRAPS - SIST. CINTURE UNIVERSALE TAV. SPINALE ST00498B DNA STRAP THORACIC BELT W/RE-WINDING SYSTEM ST00494B STX 494 - CINTURA DUE PEZZI METALLO/MOSCHETTONE ST00499B MOD. 499 THORAX BELTS ST70002A STX 702 2pcs BLACK REFLEX BELTS w/METAL BUCKLE ST02022A ECS-STR.-RES.SYS.FOR IMM. FOR SPINE BOA.&VAC. M. ST02035A ROCK STRAPS - SIST. CINTURE UNIVERS. TAV. SPINALE ST00526A STX526 CINTURA G.METALLO 2PZ.ARANCIO C/RIFRANGENTE ST00598A STX598 CINTURA GIALLA 2 PZ GANCIO IN PLASTICA ST02015A PIN STRAPS - SISTEMA DI CINTURE CON GANCI ST00594 K BELT 1 - SET 3 CINTURE STX 598 C/SACCA ST00597A STX 597 - CINTURA UN PEZZO PLASTICA ARANCIO ST04519C STX 519 ADJUST. LIFTING BRID. - LIFTING BRIDLE SYS ST02020A ROCK REFLEX FOR SPINE BOARDS ST00593A K BELT 3 - TRE CINTURE UN PEZZO STX 597 C/SACCA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FPP	Stretcher, Hand-Carried	General Hospital	Class 1	880.6900	2010-10-14
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2015-09-07
NZD	Stretcher, Patient Restraint	General Hospital	Class 1	880.6900	2010-10-15
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2010-10-15
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2014-04-30
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2015-07-13

Official Correspondent

Loredana Albano

US Agent Details

Christian Costantini Business: MACLIN POWER INC. Email: sales@maclinmed.com Phone: (786) 8187337

Related Public Records

Same Entity

Spencer Italia srl

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

View Entity Profile →

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
Z-0011-2015	Nemschoff Chairs, Inc. 909 N 8th St 2218 Julson Ct Sheboygan WI 53081-4056	1	Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12. Designed to provide patient comfort during patient treatment sessions. The chair may include a manual control reclining mechanism. Customer configurable models are also available. The Serenity III Exam 791-12E was discontinued 11/1/2010.
Z-0031-2013	Winco Mfg., LLC	1	Caremor Cliner"*Manufactured By WincoOcala, FL 34474 www.wincomfg.comModel No. 536 Serial No. 536A-101475" Literature: "Caremor Cliner 5351/5361WincoISO 9001-2008 CertifiedOur most comfortable and versatile reclinerEase of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.KEY FEATURE'SInfinite positioning backPadded armrests w/arm guardWebbed elastic suspension back and seatRemovable side panelsContinuous seat & legrest cushion5351 w/tray5361 w/out tray1.800.237.33775516 SW 1st LaneOcala, Florida 34474www.wincomfg.comProudly Made in the USA*" Patient recliner chair
Z-0032-2013	Winco Mfg., LLC	1	Caremor Cliner is labeled in part: "*Manufactured By WincoOcala, FL 34474 www.wincomfg.comModel No. 535 Serial No. 535A-104522" Literature: "Caremor Cliner 5351/5361WincoISO 9001-2008 CertifiedOur most comfortable and versatile reclinerEase of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.KEY FEATURE'SInfinite positioning backPadded armrests w/arm guardWebbed elastic suspension back and seatRemovable side panelsContinuous seat & legrest cushion5351 w/tray5361 w/out tray1.800.237.33775516 SW 1st LaneOcala, Florida 34474www.wincomfg.comProudly Made in the USA*" Patient recliner chair

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005532347. Last updated year: 2026. Please use registration number 3005532347 when referencing this establishment in official correspondence.