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Storz Medical Duolith SD1 Shock Wave Therapy

FDA PMA

Class III (US FDA PMA)

PMA P080028

by Storz Medical AG

Identity

Trade Name
STORZ MEDICAL DUOLITH SD1 SHOCK WAVE THERAPY FDA PMA
Generic Name
Generator, shock-wave, for pain relief FDA PMA

Identifiers

PMA Number
P080028 FDA PMA
FDA Product Code
NBN FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
General, Plastic Surgery FDA PMA
FDA Decision
APPR Approved FDA PMA

The Duolith SD1 Shock Wave Therapy is a Generator, shock-wave, for pain relief (Device Class III), designed to deliver extracorporeal shock wave therapy. It is intended for the non-invasive treatment of chronic heel pain caused by proximal plantar fasciitis in patients over 18 with persistent symptoms despite six months of failed conservative therapies.

This device is supplied as a reusable medical instrument and is approved under FDA_PMA (PMA Number: P080028). It operates in clinical settings where shock wave therapy is administered by trained professionals, adhering to sterile protocols. The system is not MRI-safe and requires proper storage and maintenance as specified in manufacturer guidelines.

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: directly from the manufacturer! - STORZ & BICKEL, Evidenzbasierte Stosswellentherapie & Lithotripsie (ESWT/ESWL) | STORZ ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Storz Medical AG

Sources (1)

  • FDA PMA P080028 24 fields · synced Oct 6, 2026