Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014680784

FEI Number

1825560

Entity Name

Domico Med-Device, LLC

City/State/Country

Fenton, MI, US

Establishment Address

14241 N. Fenton RD, Fenton, MI 48430, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Domico Med-Device (Owner Number: 10057806)

Owner / Operator Contact Address

14241 N. Fenton RD, Fenton, MI 48430, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cord Management Drape Wedge Cushion Arm Support Cushion Head Cushion Insert Set Head Cushion Insert Set Wedge Cushion Arm Support Cushion Med Vac; Arm splints; Child splints; Dual leg splints; Hand, Foot, Wrist, Ankle, Leg Splints; Head splints; Infant Splin Buffing Pad, Arthroscope Arm Support Cushion Head Cushion Insert Set Wedge Cushion Arm splints; Child splints; Dual leg splints; Hand, Foot, Wrist, Ankle, Leg Splints; Head splints; Infant Splints Med Vac; Arm splints; Child splints; Dual leg splints; Hand, Foot, Wrist, Ankle, Leg Splints; Head splints; Infant Splin Domico

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2022-05-16
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	2021-07-02
KXJ	Table, Radiologic	Radiology	Class 2	892.1980	2018-06-19
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2026-01-28
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2018-06-19
QCI	Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder	Neurology	Class 2	882.5802	2024-08-06
JEB	Table, Surgical With Orthopedic Accessories, Manual	General, Plastic Surgery	Class 1	878.4950	2024-09-18
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2024-08-06
PRN	Pediatric Position Holder	General Hospital	Class 1	880.5680	2018-09-07
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2020-02-24
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2018-07-27
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2018-09-07
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2024-09-11
OBP	Transcranial Magnetic Stimulator	Neurology	Class 2	882.5805	2024-08-06
IWY	Holder, Head, Radiographic	Radiology	Class 1	892.1920	2018-06-01
FPP	Stretcher, Hand-Carried	General Hospital	Class 1	880.6900	2020-07-02
LWG	Surgical Table Cushion	General, Plastic Surgery	Class 1	878.4950	2019-01-11
FZF	Splint, Extremity, Inflatable, External	General, Plastic Surgery	Class 1	878.3900	2018-05-29
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2021-04-12
EAJ	Apron, Leaded	Radiology	Class 1	892.6500	2019-01-29
IXA	Cassette, Radiographic Film	Radiology	Class 2	892.1850	2020-07-02

Official Correspondent

Domico Med-Device

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Domico Med-Device

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005588647	KOHLBRAT & BUNZ	Radstadt Salzburg, AT
3042941605	Domico Med-Device, LLC	Las palomas Guanajuato, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13
K812396	Northwest Surgical Concepts, Inc.	ARTHRO-PREP REST	1981-11-20
K962327	Sekure Seat Corp.	SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE	1997-03-06
K963243	Heelbo, Inc.	HEELBO BLAZER SLEEVED JACKET	1996-10-01
K243700	Mag & More GmbH	Apollo TMS Therapy System	2025-09-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0040-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0041-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 4mm Offset (Purple Catalog Number: 72201714 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0042-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 5mm Offset (Red) Catalog Number: 72201715 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0043-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 6mm Offset (Green) Catalog Number: 72201716 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0044-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 7mm Offset (Gold) Catalog Number: 72201717 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.

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3011219098	MFG AMP	Tijuana Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014680784. Last updated year: 2026. Please use registration number 3014680784 when referencing this establishment in official correspondence.