Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007309299

FEI Number

3007309299

Entity Name

AccuMed Corp.

City/State/Country

Nigua San Cristobal, DO

Establishment Address

Carretera Sanchez KM 20, Zona Franca de Nigua, Nigua San Cristobal 91000, DO

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

AccuMed Corp (Owner Number: 10040676)

Owner / Operator Contact Address

Parque Industrial Itabo KM 18 1/2, Antigua Carretera Sanchez, Building 10 Haina, San Cristobal, DO-21 91000, DO

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bone Growth Extension Strap Lateral Air Mattress DEVICE, TRANSFER, PATIENT, MANUAL T7 Hood with Peel Away Face Shield T7 Hood with Anti-Reflective Face Shield T7Plus Hood with Peel Away Face Shield T7Plus Hood with Anti-Reflective Face Shield pd belt System, monitoring, perinatal Disposable abdominal belt M2208A DISPOSABLE HIGH II, SIZE M/L DISP HIGH BARIATRIC XXL/XXXL DISP HIGH BARIATRIC, SIZE XL/XXL DISP HIGH BARIATRIC, SIZE LXL DISPOSABLE LEG SLING II DISPOSABLE HIGH II, SIZE L/XL DISPOSABLE REPOSITION SLING DISPOSABLE TWIN TURNER II LG DISPOSABLE HIGH II SIZE XL/XXL DISPOSABLE HIGH II, KIDS 6-10 DISPOSABLE TWIN TURNER II REG DISPOSABLE HORIZONTAL SLING DISPOSABLE HIGH II, SIZE XS/S DISPOSABLE HIGH II, SIZE S/M Lift, patient, non-ac-powered TPOD Trauma PElvic Orthotic Device ORTHOSIS, LUMBO-SACRAL MATTRESS, FLOTATION THERAPY, NON-POWERED MDT821203 Gait Belt Single Patient Use Wraps

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2009-02-19
IOQ	Bed, Flotation Therapy, Powered	Physical Medicine	Class 2	890.5170	2014-03-11
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2011-01-20
FXY	Hood, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-06-09
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2018-02-02
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2011-09-21
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2011-01-04
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2020-09-01
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2020-09-01
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	2018-07-11
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2015-09-24
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2020-10-23
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2020-09-01
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2009-02-19
BYI	Percussor, Powered-Electric	Anesthesiology	Class 2	868.5665	2011-08-21

Official Correspondent

Zoila Jimenez

US Agent Details

Kent McKesson Email: kwmckesson@creativefoam.com Phone: (574) 2484883

Related Public Records

Same Entity

AccuMed Corp

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011219270	AccuMED Corp.	Haina San Cristobal, DO

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K890935	Dermanetics Corp.	SYSTEM 3000 FLUIDIZED AIR BED	1989-03-15
K771196	Hewlett-Packard Co.	MARKER GENERATOR MODULES - 21597A	1977-08-03
K813458	Cranbury Medical Labs, Inc.	FETASCAN 1000, 1000A OBSTETRICAL DATA	1982-01-28
K100420	Philips Medizin Systeme Boeblingen GmbH	PHILIPS OBTRACEVUE MODEL SW REV. G.00	2010-07-26
K173941	Philips Medizin Systeme Boeblingen GmbH	IntelliSpace Perinatal Rev.K.00	2018-09-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-06	VIASYS Med Systems	2	Stackhouse FreedomAire Lens/Hood; a sterile disposable protective head garment for use with the FreedomAire Surgical Helmet System, providing a clear plastic bubble lens and protective head hood to connect to the surgical helmet; individually packaged hoods, 12 per case; Manufactured for Viasys MedSystems, Wheeling, IL 60090
Z-0002-06	VIASYS Med Systems	2	Stackhouse Lens/Hood, Mark III Universal; a sterile disposable protective head garment for use with the Stackhouse Mark III Helmet, providing a clear plastic bubble lens and protective head hood to connect to the surgical helmet; individually packaged hoods, 12 per case; Manufactured for Viasys MedSystems, Wheeling, IL 60090
Z-0035-06	N/A	2	FETALGARD Lite Fetal Monitors, Model AP1S (Single Fetus Monitoring)
Z-0036-06	N/A	2	FETALGARD Lite Fetal Monitors, Model HCS (Home Care Single Fetus Monitoring)
Z-0013-2018	Handicare Usa Inc	1	PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007309299. Last updated year: 2026. Please use registration number 3007309299 when referencing this establishment in official correspondence.