Data / Medical devices / United States / Kmi Imi Group / Dba: Innovative Med, Inc.
Kmi Imi Group / Dba: Innovative Med, Inc.: FDA-registered device maker in Irvine, CA, United States, 9 510(k) clearances
Kmi Imi Group / Dba: Innovative Med, Inc. is registered with the FDA (registration 3004112621) in Irvine, CA, United States. It lists 23 device types. The FDA files 9 510(k) clearances under its listings, the newest dated October 29, 2018. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3004112621
- Address
- 4 Autry Suite B, Irvine, CA, United States, 92618
- Owner or operator
- KMI IMI GROUP / DBA INNOVATIVE MED, INC. (9058238)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- August 25, 2003
- Registered through
- 2026
- Brand names listed
- ABDOMINAL BINDERS, ATTS SYSTEM, Adipose, Aptos, Automated blood cell separator, CELLUMAGE, Cannula, Carbomed and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 29, 2018 | K181239 | Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer | FLL | Substantially Equivalent | Joytech Healthcare Co. , Ltd. | accessdata.fda.gov |
| August 23, 2010 | K093204 | INNOVATIVE MED MULTI WAVE LIGHT THERAPY SYSTEM | ILY | Substantially Equivalent | Innovative Med, Inc. | accessdata.fda.gov |
| March 4, 2005 | K043591 | FEATHERLIFT EXTENDED APTOS THREAD | GAW | Substantially Equivalent | Kmi Kolster Methods, Inc. | accessdata.fda.gov |
| July 2, 2002 | K020386 | INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02 | CAW | Substantially Equivalent | Invacare Corp. | accessdata.fda.gov |
| November 19, 2001 | K012236 | STARS2000 POWER CANNULA | QPB | Substantially Equivalent | Kmi Kolster Methods, Inc. | accessdata.fda.gov |
| August 9, 2001 | K010702 | XUB EXTERNAL ULTRASOUND | IMI | Substantially Equivalent | Kmi Kolster Methods, Inc. | accessdata.fda.gov |
| October 15, 1999 | K991203 | IRRIGATION OR INFUSION PUMP K PUMP | FRN | Substantially Equivalent | Kmi Kolster Methods, Inc. | accessdata.fda.gov |
| October 18, 1989 | K895762 | CANULA SUCTION FOR SURGICAL GENERAL AND PLASTIC | GEA | Substantially Equivalent | Kolster Methods | accessdata.fda.gov |
| October 18, 1989 | K895761 | GENERAL ASPERATOR | JCX | Substantially Equivalent | Kolster Methods | accessdata.fda.gov |
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Updated October 29, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.