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Sign in to claim this brandACESSA HEALTH INC.
US
Last updated May 23, 2026
What ACESSA HEALTH INC. makes
Acessa Health Inc. manufactures radio-frequency ablation systems designed for precise tissue treatment, including handpieces, cables, and field generators for surgical applications. Their portfolio also includes electromagnetic surgical navigation devices for real-time tracking during procedures, as well as ultrasound imaging transducers for intraoperative visualization. These products are used in surgical settings to enhance procedural accuracy and safety.
The company’s devices fall under FDA Class II regulatory classification, requiring pre-market notification (510(k)) and unique device identification (UDI) compliance. These products are listed in the FDA’s 510(k) and UDI registries, adhering to U.S. medical device regulations. The manufacturer 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 Acessa Health Inc. manufacture?
Acessa Health Inc. specializes in surgical and ablation technologies. Their primary products include radio-frequency ablation systems—such as handpieces, cables, and field generators—to enable precise tissue treatment. They also develop electromagnetic surgical navigation systems for real-time tracking during procedures and ultrasound imaging transducers for intraoperative visualization. These devices are designed to improve accuracy and safety in surgical environments.
Where is Acessa Health Inc. based?
Acessa Health Inc. is headquartered in the United States. The company’s location ensures compliance with U.S. medical device regulations, including those governing its Class II devices.
Which regulatory registries list Acessa Health Inc.’s devices?
Acessa Health Inc.’s devices are included in the FDA’s 510(k) and Unique Device Identification (UDI) registries. These listings reflect compliance with U.S. requirements for Class II devices, which mandate pre-market notification and UDI assignment.
How are Acessa Health Inc.’s devices classified by the FDA?
Acessa Health Inc.’s devices fall under FDA Class II classification. This classification requires manufacturers to submit a 510(k) pre-market notification to demonstrate substantial equivalence to a predicate device and comply with UDI regulations. Class II devices are considered moderate-risk and require additional controls beyond general controls.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 080935394
Catalogue (11)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Acessa Pad Cable | 4300 | FDA UDI | Class II | Active |
| Acessa ProVu Dual Foot Pedal | MS-06-0171 | FDA UDI | Class II | Active |
| Acessa Pads | 3000 | FDA UDI | Class II | Active |
| Acessa Table Top Field Generator | 5200 | FDA UDI | Class II | Active |
| Acessa ProVu System | 7100 | FDA UDI | Class II | Active |
| Acessa ProVu Transducer with sensor | 7700 | FDA UDI | Class II | Active |
| Acessa ProVu Planar Field Generator (PFG) | 8100 | FDA UDI | Class II | Active |
| Acessa ProVu Handpiece | 7300 | FDA UDI | Class II | Active |
| Acessa ProVu Handpiece Cable | 7400 | FDA UDI | Class II | Active |
| Acessa ProVu PFG Table Clamp | MS-05-0257 | FDA UDI | Class II | Active |
| Acessa ProVu System | K181124 | FDA 510(k) | Class II | Active |
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