Is this your brand? Sign in to claim ownership.
Sign in to claim this brandVitaheat Medical, LLC
US
Last updated May 23, 2026
What Vitaheat Medical, LLC makes
Vitaheat Medical, LLC manufactures electric pad whole-body heating systems for patient warming, including reusable power supplies, battery chargers, and disposable batteries. Their portfolio includes external electric-heating core temperature regulation systems, consisting of control units and heating pads, as well as standalone warming mattress systems. These devices are designed for use in clinical settings to maintain or restore patient body temperature during medical procedures.
The company’s products are classified as Class II medical devices under FDA regulations and are listed in the FDA’s 510(k) and UDI registries. Vitaheat Medical, LLC 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 Vitaheat Medical, LLC primarily manufacture?
Vitaheat Medical, LLC specializes in electric pad whole-body heating systems designed for patient warming in clinical settings. Their portfolio includes reusable power supplies, battery chargers, disposable batteries, and external electric-heating core temperature regulation systems. These systems consist of control units and heating pads, as well as standalone warming mattress systems. The devices are intended to maintain or restore patient body temperature during medical procedures.
Where is Vitaheat Medical, LLC based?
Vitaheat Medical, LLC is headquartered in the United States. The company’s location is relevant for regulatory compliance and understanding its operational base, particularly when reviewing device listings and classifications under U.S. medical device regulations.
Which regulatory registries list Vitaheat Medical, LLC’s devices?
Vitaheat Medical, LLC’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. The 510(k) registry documents premarket submissions for Class II devices, while the UDI system ensures standardized identification of medical devices for tracking and compliance purposes.
How are Vitaheat Medical, LLC’s devices classified under FDA regulations?
Vitaheat Medical, LLC’s devices are classified as Class II medical devices by the FDA. This classification applies to products that generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as patient warming systems that help regulate body temperature during medical procedures.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (11)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Battery | 100026 | FDA UDI | Class II | Active |
| AC Power Adapter Subassembly Kit | 1000026-PA-SA | FDA UDI | Class II | Active |
| VitaHEAT UB3 Patient Warming System- Battery and AC Power | 7003-C | FDA UDI | Class II | Active |
| VitaHEAT UB3 Patient Warming System - AC Power | 7003-B | FDA UDI | Class II | Active |
| VitaHEAT UB3 Patient Warming System - Battery Power | 7003-A | FDA UDI | Class II | Active |
| Patient Warming Mattress | 4003 | FDA UDI | Class II | Active |
| Battery Power Subassembly | 300126 | FDA UDI | Class II | Active |
| Controller | 2002 | FDA UDI | Class II | Active |
| Battery Charger | 3001-C | FDA UDI | Class II | Active |
| AC Power Adapter | 100026-PA | FDA UDI | Class II | Active |
| Vitaheat Patient Warming System | K132454 | 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.