Data / Medical devices / United States / Adroit Medical Systems, Inc.
Adroit Medical Systems, Inc.: FDA-registered device maker in Loudon, TN, United States, 3 510(k) clearances
Adroit Medical Systems, Inc. is registered with the FDA (registration 1055823) in Loudon, TN, United States. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 6, 2008. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1055823
- FEI number
- 1000111140
- Address
- 1146 Carding Machine RD., Loudon, TN, United States, 37774
- Owner or operator
- ADROIT MEDICAL SYSTEMS, INC. (9005173)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- February 9, 2001
- Registered through
- 2027
- Brand names listed
- Currie Medical, HTP-1500, Medi-Choice, Mistral-Air, Sheathing Technologies, Soft-Air, Soft-Temp, ThermalX
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Drape, Surgical, Exempt | PUI | 2 | Contract manufacturer | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Water Circulating | ILO | 2 | Manufacturer | accessdata.fda.gov |
| System, Thermal Regulating | DWJ | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Contract manufacturer | 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 |
|---|---|---|---|---|---|---|
| June 6, 2008 | K073712 | SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100 | DWJ | Substantially Equivalent | Adroit Medical Systems, Inc. | accessdata.fda.gov |
| September 10, 1997 | K970197 | HTP-1500 LOCALIZED HEAT THERAPY PUMP | ILO | Substantially Equivalent | Adroit Medical Systems, Inc. | accessdata.fda.gov |
| December 11, 1992 | K921920 | SOFT-TEMP | DWJ | Substantially Equivalent | Adroit Medical Systems, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Thermal Regulating
- All makers of Pack, Hot Or Cold, Water Circulating
- All makers of Gown, Examination
- All makers of Drape, Surgical, Exempt
- All makers of Transducer, Ultrasonic, Diagnostic
Updated June 6, 2008. 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.