Is this your brand? Sign in to claim ownership.
Sign in to claim this brandAdroit Medical Systems, Inc.
United States·US-MF-000004898
Last updated September 17, 2026
About
Gene Gammons, our founder, started his career path developing a disposable blood and urine collection system for a chemist with Eli Lilly. His success led him to invent a sterile hypo-hyperthermia water blanket, in the 1970’s, that was designed to safely return post-surgical patient’s temperature to normal, increase blood flow and promote healing. For years, Gene was the sole producer of the hypo-hyperthermia water blanket. “It was the first in the country, the first in the world” Gene says. When the patent expired in 1991, he was able to start Adroit Medical.
From the manufacturer's own website. Source
What Adroit Medical Systems, Inc. makes
Adroit Medical Systems produces circulating-air and circulating-fluid thermal therapy systems, including whole-body heating control units, single-use localized thermal therapy packs, and external core temperature regulation systems for heating and cooling. Their product line also includes single-use patient gowns and accessories for thermal therapy devices, such as the HTP1500 Bed Bracket.
The company’s devices are classified as Class I and Class II under FDA regulations, with submissions recorded in the 510(k) and UDI registries. Adroit Medical Systems is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Adroit Medical Systems, Inc. manufacture?
Adroit Medical Systems, Inc. specializes in thermal therapy devices, including circulating-air and circulating-fluid systems. Their product line covers whole-body heating control units, single-use localized thermal therapy packs, external core temperature regulation systems for heating and cooling, and single-use patient gowns. These devices are designed for temperature management in medical settings, such as post-surgical recovery or therapeutic cooling.
Where is Adroit Medical Systems, Inc. based?
Adroit Medical Systems, Inc. is headquartered in the United States. The company’s location is relevant for regulatory compliance, as it operates under U.S. medical device regulations, including FDA requirements.
Which regulatory registries list Adroit Medical Systems’ devices?
Adroit Medical Systems’ devices are recorded in the FDA’s 510(k) and UDI (Unique Device Identification) registries. The 510(k) process is used for premarket submissions to demonstrate substantial equivalence to existing devices, while the UDI system ensures traceability and identification of medical devices in the market.
How are Adroit Medical Systems’ devices classified under FDA regulations?
Adroit Medical Systems’ devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway and oversight required for each device.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 1146 Carding Machine Road, Loudon, United States
- Website
- adroitmedical.com
- —
- —
- [email protected]
- Phone
- 8654588600
- PRRC Contact
- Edward Tymitz
- EUDAMED SRN
- US-MF-000004898
- FDA FEI Number
- 1000111140
- DUNS Number
- —
Catalogue (124)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Soft Air | A545 | FDA UDI | Class II | Active |
| Soft Air | A265 | FDA UDI | Class II | Active |
| Soft Air | A555 | FDA UDI | Class II | Active |
| Soft Air | A220R | FDA UDI | Class II | Active |
| Soft Air | A315R | FDA UDI | Class II | Active |
| Soft-Temp | ST-217 | FDA UDI | Class II | Active |
| Soft-Temp | ST-018 | FDA UDI | Class II | Active |
| ThermalX | 352 | FDA UDI | Class I | Active |
| Soft Air | A522 | FDA UDI | Class II | Active |
| Htp1500 | HTPS1500 | FDA UDI | Class II | Active |
| Soft-Temp | ST-212 | FDA UDI | Class II | Active |
| Soft-Temp | ST-031 | FDA UDI | Class II | Active |
| Surface Warming & Cooling System | A3 | FDA UDI | Class II | Active |
| Soft-Temp | ST-014 | FDA UDI | Class II | Unknown |
| ThermalX | 651 | FDA UDI | Class I | Active |
| ThermalX | 951 | FDA UDI | Class I | Active |
| HTP1500 Accessory | TFR-1 | FDA UDI | Class II | Active |
| ThermalX | 351 | FDA UDI | Class I | Active |
| Safepass Sterilization Pouch | K973981 | FDA 510(k) | Class II | Active |
| Soft Air, Model Sa 4000 And Mistral Air, Model Ma0100 | K073712 | FDA 510(k) | Class II | Active |
| Sterile Soft-Temp | K962983 | FDA 510(k) | Class II | Active |
| Htp-1500 Localized Heat Therapy Pump | K970197 | FDA 510(k) | Class II | Active |
| Soft-Cover | K921928 | FDA 510(k) | Class I | Active |
| Soft-Temp | K921920 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.