Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004112621

FEI Number

3004112621

Entity Name

KMI IMI GROUP / DBA: INNOVATIVE MED, INC.

City/State/Country

IRVINE, CA, US

Establishment Address

4 Autry Suite B, IRVINE, CA 92618, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

KMI IMI GROUP / DBA INNOVATIVE MED, INC. (Owner Number: 9058238)

Owner / Operator Contact Address

4 AUTRY, Irvine, CA 92618, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K012236

PMA Number

N/A

All Registered Proprietary Names

CELLUMAGE IMI REGULATOR Carbomed K PUMP IM-RIKD IM-AFTD IM-DIK IM-SFRT IM-ITD IM-CGT IM-AFTDY IM-HFTD IM-ITDY IM-CGTY INFINITY TEETH WHITENING SYSTEM ATTS SYSTEM FatSilk Diamond Filter Diamond Cut Fat Silk SETAREH PEEL-1150 SaltFacial SETAREH PEEL-2150MD IMAGE PEEL-1100 Skin Booster IMI, PHANTOM HYDRABRASION PORTAPEEL 1050, 4150, 6160; OXYGLOW DERMAGLOW Skin Booster MULTIWAVE LIGHT THERAPY DEVICES, OXYGLOW INFRARED THERMOMETER IMI EMBILICAL LOCATOR ABDOMINAL BINDERS Automated blood cell separator Healeon HD PRP, ProGen PRP IMI DISSECTORS SUCTION CANNULA, IMI; SUCTION CANNULA, KMI PURE SCULPT POWER CANNULA SYSTEM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYG	Massager, Therapeutic, Manual	Physical Medicine	Class 1	890.5660	2007-12-06
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2006-05-24
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2005-10-18
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2009-09-01
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2007-12-14
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2010-07-15
KET	Filters, Cell Collection, Tissue Processing	Pathology	Class 1	864.3010	2019-06-05
GFE	Brush, Dermabrasion, Powered	General, Plastic Surgery	Class 1	878.4820	2003-08-25
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered	General, Plastic Surgery	Class 2	878.4780	2005-10-27
GFD	Dermatome	General, Plastic Surgery	Class 1	878.4820	2007-06-29
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2012-12-20
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-05-04
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2009-01-05
FSD	Binder, Abdominal	General Hospital	Class 1	880.5160	2005-10-18
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2021-03-25
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2005-10-18
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2005-10-18
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	Class 2	878.5040	2007-12-28

Official Correspondent

Natalie Cruze

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

KMI IMI GROUP / DBA INNOVATIVE MED, INC.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K913718	Abbott Laboratories	PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED	1991-10-30
K840616	Advanced Bio Systems, Inc.	MINI-PUMP U-100	1984-03-30
K850183	Deltec Systems, Inc.	CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M	1985-03-13
K082762	Aardvark Medical	AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE	2008-11-12
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0037-2010	Airgas Puritan Medical Puritan Medical Unit	1	AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders.
Z-0038-2010	Airgas Puritan Medical Puritan Medical Unit	1	AGI-2238 Portable 4 Cylinder Manifold Cart, for connecting medical gas cylinders.
Z-0001-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161, and 2M9161.
Z-0002-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product codes: 2M8153, and 2M8163.
Z-0005-2025	Zyno Medical LLC	2	Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004112621. Last updated year: 2026. Please use registration number 3004112621 when referencing this establishment in official correspondence.