Data / Medical devices / United States / KT Health, LLC
KT Health, LLC: FDA-registered device maker in American Fork, UT, United States, 1 510(k) clearance
KT Health, LLC is registered with the FDA (registration 3007282994) in American Fork, UT, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 31, 2020. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007282994
- Address
- 584 East 1100 South Suite 4, American Fork, UT, United States, 84003
- Owner or operator
- Bridges Consumer Healthcare (10027415)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- October 31, 2012
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Elastic | FQM | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Complaint file establishment | accessdata.fda.gov |
| Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain | PQY | 2 | Complaint file establishment | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Complaint file establishment, Repackager or relabeler, 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 |
|---|---|---|---|---|---|---|
| January 31, 2020 | K192234 | ActiPatch | PQY | Substantially Equivalent | Bioelectronics Corporation | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 16, 2019 | 85315 | Class II | Terminated | KT RECOVERY+ ICE/HEAT MASSAGE BALL Rolling ball with hot and cold packs that can be interchanged depending on the therapy type desired | If over-heated may leak which, if not noticed, may cause hot fluid to come in contact with the user. | accessdata.fda.gov |
Compare with other makers
- All makers of Pack, Hot Or Cold, Reusable
- All makers of Bandage, Elastic
- All makers of Dressing, Wound, Occlusive
Updated January 31, 2020. 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.