EMS SWISS DOLORCLAST
FDA premarket approval P050004 · decided 2007-05-08
Approval details
- PMA number
- P050004
- Trade name
- EMS SWISS DOLORCLAST
- Generic name
- Generator, shock-wave, for pain relief
- Applicant
- Electro Medical Systems (Ems Sa)
- Date received
- 2005-02-02
- Decision date
- 2007-05-08
- Days to decision
- 825 days
- Decision code
- APPR
- Product code
- NBN
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Nyon
- Statement
- APPROAL FOR THE EMS SWISS DOLORCLAST. THE EMS SWISS DOLORCLAST IS A NON-SURGICAL ALTERNATIVE INDICATED FOR THE TREATMENT OF CHRONIC PROXIMAL PLANTAR FASCIITIS FOR PATIENTS 18 YEARS OF AGE OR OLDER WITH SYMPTOMS FOR 6 MONTHS OR MORE AND A HISTORY OF UNSUCCESSFUL CONSERVATIVE THERAPY. CHRONIC PROXIMAL PLANTAR FASCIITIS IS DEFINED AS HEEL PAIN IN THE AREA OF THE INSERTION OF THE PLANTAR FASCIA ON THE MEDICAL CALCANEAL TUBEROSITY.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| PIEZON MASTER 400 (K896749) | Electro Medical Systems (Ems Sa) | 1990-08-31 |
| AIR FLOW SII (K900709) | Electro Medical Systems (Ems Sa) | 1990-04-18 |