Data / Medical devices / United States / Care Line, Inc.
Care Line, Inc.: FDA-registered device maker in Greenbrier, TN, United States, 1 510(k) clearance
Care Line, Inc. is registered with the FDA (registration 1034116) in Greenbrier, TN, United States. It lists 15 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 24, 2011. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1034116
- Address
- 2210 Lake RD., Greenbrier, TN, United States, 37073
- Owner or operator
- CARE LINE, INC. (1034116)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- February 25, 2002
- Registered through
- 2026
- Brand names listed
- Care Line, Care Line cold pack, GENERIC
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Basin, Emesis | FNY | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bedpan | FOB | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Container, Liquid Medication, Graduated | KYW | 1 | Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Cover, Mattress (Medical Purposes) | FMW | 1 | Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Mattress, Flotation Therapy, Non-Powered | IKY | 1 | Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Patient Personal Hygiene Kit | NSB | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Thermometer, Clinical Color Change | FQZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Urinal | FNP | 1 | Complaint file establishment, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| August 24, 2011 | K110776 | DIGITAL THERMOMETER MT SERIES | FLL | Substantially Equivalent | Sejoy Electronics & Instruments Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Urinal
- All makers of Toothbrush, Manual
- All makers of Container, Liquid Medication, Graduated
- All makers of Thermometer, Clinical Color Change
- All makers of Patient Personal Hygiene Kit
- All makers of Bedpan
Updated August 24, 2011. 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.