Identity
- Trade Name
- EMS SWISS DOLORCLAST FDA PMA
- Generic Name
- Generator, shock-wave, for pain relief FDA PMA
Identifiers
- PMA Number
- P050004 FDA PMA
- FDA Product Code
- NBN FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Orthopedic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The EMS Swiss Dolorclast is a shock-wave generator for pain relief, classified as a Class III medical device. It is indicated as a non-surgical alternative for the treatment of chronic proximal plantar fasciitis in patients 18 years of age or older with symptoms lasting six months or more and a history of unsuccessful conservative therapy.
This device is supplied by Electro Medical Systems (Ems Sa) and has received FDA PMA approval under PMA number P050004. It is intended for use in clinical settings under professional supervision, with no claims made regarding sterility, single-use status, MRI safety, sizes, or storage conditions in the provided data.
Frequently asked questions
What is the EMS Swiss Dolorclast indicated to treat?
The EMS Swiss Dolorclast is indicated for the treatment of chronic proximal plantar fasciitis in patients 18 years of age or older who have experienced symptoms for six months or more and have a history of unsuccessful conservative therapy, as defined by heel pain at the insertion of the plantar fascia on the medial calcaneal tuberosity.
What type of device is the EMS Swiss Dolorclast classified as?
The EMS Swiss Dolorclast is classified as a Generator, shock-wave, for pain relief, and is assigned to device class III under the FDA’s product code NBN.
What regulatory authorization does the EMS Swiss Dolorclast have?
The EMS Swiss Dolorclast has received FDA Premarket Approval (PMA) under PMA number P050004, with the decision date of May 8, 2007, and the docket number 07M-0253.
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 | P050004 | Class III | Active |
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Manufacturer
- Manufacturer
- Electro Medical Systems (Ems Sa)
Sources (1)
- FDA PMA P050004 24 fields · synced Sep 18, 2026