Identity
- Trade Name
- DORNIER EPOS ULTRA FDA PMA
- Generic Name
- Generator, shock-wave, for pain relief FDA PMA
Identifiers
- PMA Number
- P000048 FDA PMA
- FDA Product Code
- NBN FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Orthopedic FDA PMA
- FDA Decision
- APWD FDA PMA
The Dornier EPOS Ultra is a shock-wave generator designed for pain relief, specifically indicated as a non-surgical alternative for the treatment of chronic plantar fasciitis. It targets the traction degeneration of the plantar fascial band at its origin on the medial tubercle of the calcaneus in patients with symptoms lasting six months or more and a history of unsuccessful conservative therapy.
It is supplied as a reusable device for use in clinical settings, requiring appropriate training for operation. The device is regulated under FDA PMA (P000048) and is classified as a Class III medical device. No claims regarding sterility, single-use status, MRI safety, or storage conditions are made in the provided data.
Frequently asked questions
What condition is the Dornier EPOS Ultra intended to treat?
The Dornier EPOS Ultra is intended for the treatment of chronic plantar fasciitis in patients who have experienced symptoms for six months or more and have a history of unsuccessful conservative therapy, as it provides a non-surgical alternative targeting the traction degeneration of the plantar fascial band at its origin on the medial tubercle of the calcaneus.
Is the Dornier EPOS Ultra a surgical device?
No, the Dornier EPOS Ultra is explicitly described as a non-surgical alternative for treating chronic plantar fasciitis, meaning it does not require surgical intervention for its application.
What regulatory pathway was used for the Dornier EPOS Ultra?
The Dornier EPOS Ultra received approval through the FDA Premarket Approval (PMA) pathway, as indicated by the authorization field FDA_PMA and the PMA number P000048 in the device data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Dornier MedTech - A Leading Urological Medical Device Company
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P000048 | Class III | Active |
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Manufacturer
- Manufacturer
- Dornier MedTech America, Inc.
Sources (1)
- FDA PMA P000048 24 fields · synced Oct 6, 2026