Orthospec Extracorporeal Shock Wave Therapy Device
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY DEVICE FDA PMA
- Generic Name
- Generator, shock-wave, for pain relief FDA PMA
Identifiers
- PMA Number
- P040026 FDA PMA
- FDA Product Code
- NBN FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Physical Medicine FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Orthospec Extracorporeal Shock Wave Therapy Device is a Generator, shock-wave, for pain relief (Device Class III), designed as a non-invasive treatment modality. It delivers focused extracorporeal shock waves to target tissue, specifically indicated for managing symptoms of proximal plantar fasciitis with or without heel spurs in patients aged 18 and older. The device operates as an alternative to surgical intervention for chronic heel pain resistant to conservative therapies.
This device is supplied as a reusable medical instrument and is approved for use in clinical settings under FDA_PMA (PMA Number: P040026). It requires proper training for operation and adherence to manufacturer guidelines for safety and efficacy. The device is not intended for MRI environments, and its shock wave parameters are pre-set for the specified indication. Storage and maintenance must comply with regulatory and manufacturer instructions to ensure device integrity and performance.
Frequently asked questions
What is the Orthospec Extracorporeal Shock Wave Therapy Device used for in clinical practice?
The Orthospec device is a non-invasive treatment designed specifically for managing symptoms of proximal plantar fasciitis, including cases with heel spurs, in patients aged 18 and older. It serves as an alternative to surgery for chronic heel pain that has persisted for six months or longer and has not responded to conventional therapies like rest, stretching, or medication.
Is the Orthospec device single-use or reusable, and what does that mean for maintenance?
The Orthospec device is supplied as a reusable medical instrument, meaning it is intended for repeated use in clinical settings. Proper maintenance and adherence to manufacturer guidelines are required to ensure its performance and safety between treatments, including regular cleaning and storage as specified by Medispec, Ltd.
Who should operate the Orthospec device, and what training is required?
The Orthospec device requires proper training for operation, as it is not intended for self-administration. Clinicians or trained professionals must follow manufacturer guidelines to ensure safe and effective use, particularly given its classification as a Class III medical device and its role in treating chronic heel pain.
Can the Orthospec device be used in all clinical environments, or are there restrictions?
The Orthospec device is not approved for use in MRI environments. Its shock wave parameters are pre-set for the specified indication (proximal plantar fasciitis), and its operation must comply with regulatory and manufacturer instructions to maintain device integrity and performance.
How is the Orthospec device regulated, and what does that mean for purchasing or using it?
The Orthospec device is regulated under an FDA Premarket Approval (PMA) process, with PMA Number P040026. This means it has undergone rigorous review by the FDA to demonstrate safety and effectiveness for its intended use—treating proximal plantar fasciitis in patients 18 and older. Purchasers or users should ensure compliance with FDA and manufacturer guidelines to maintain regulatory compliance.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P040026 | Class III | Active |
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Manufacturer
- Manufacturer
- Medispec, Ltd.
Sources (1)
- FDA PMA P040026 24 fields · synced Sep 18, 2026