Data / Medical devices / United States / Focus Health Group
Focus Health Group: FDA-registered device maker in Knoxville, TN, United States, 12 510(k) clearances
Focus Health Group is registered with the FDA (registration 3006802076) in Knoxville, TN, United States. It lists 9 device types. The FDA files 12 510(k) clearances under its listings, the newest dated December 16, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006802076
- Address
- 5802 Kingston Pike, Knoxville, TN, United States, 37919
- Owner or operator
- Focus Health Group (10060699)
- Roles
- Specification developer
- First device listed
- July 10, 2019
- Registered through
- 2026
- Brand names listed
- Epinephrine Professional, Sub Occipital Bandage, ZENIGEL-AG Silver Amorphous Wound Gel, ZeniABSORB Border Plus, ZeniAbsorb, ZeniCol, ZeniCol AG, ZeniCol Collagen Dressing and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bladder Irrigation Kit | PPA | 2 | Specification developer | accessdata.fda.gov |
| Closure, Wound, Adhesive | MGO | 1 | Specification developer | accessdata.fda.gov |
| Dressing, Compression | MHW | 1 | Specification developer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Specification developer | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Specification developer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Specification developer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Specification developer | accessdata.fda.gov |
| First Aid Kit With Drug | LRR | N | Specification developer | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | Specification developer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| December 16, 2024 | K240809 | LUOFUCON® Silver Collagen Dressing | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| April 25, 2024 | K232796 | LUOFUCON® Collagen Particles (Collagen Wound Dressing) | KGN | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| September 20, 2022 | K213598 | LUOFUCON Collagen Wound Dressing | KGN | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| April 22, 2022 | K211123 | LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| March 30, 2017 | K170077 | LUOFUCON Silicone Ag Foam Dressing with Border | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| August 17, 2016 | K160022 | LUOFUCON Silicone Ag foam dressing | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| April 6, 2015 | K141619 | LUOFUCON SILVER FOAM DRESSING | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| March 23, 2015 | K140954 | LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| February 14, 2013 | K120181 | LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| October 26, 2012 | K122325 | SKINTEMP II | KGN | Substantially Equivalent | Human Biosciences, Inc. | accessdata.fda.gov |
| April 18, 2006 | K060804 | COLLAGRAN-COLLAGEN WOUND DRESSING, COLLAGRANAG-COLLAGEN W/SILVER ANTIMICROBIAL WOUND DRESSING | FRO | Substantially Equivalent | Covalon Technologies, Ltd. | accessdata.fda.gov |
| April 2, 1991 | K910944 | MEDIFIL | KGN | Substantially Equivalent | Biocore | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Drug
- All makers of Dressing, Wound, Hydrogel Without Drug And/Or Biologic
- All makers of Wound Dressing With Animal-Derived Material(S)
- All makers of Closure, Wound, Adhesive
- All makers of Dressing, Wound, Hydrophilic
- All makers of First Aid Kit With Drug
Updated December 16, 2024. 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.