PMA P040026
- Device
- ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY DEVICE
- Applicant
- Medispec, Ltd.
- PMA number
- P040026
- Product code
- NBN
- Decision date
- 2005-04-01
- Generic name
- Generator, shock-wave, for pain relief
- Approval order statement
- APPROVAL FOR THE ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY DEVICE. THE DEVICE IS INDICATED FOR THE TREATMENT OF PROXIMAL PLANTAR FASCIITIS WITH OR WITHOUT HEEL SPUR IN PATIENTS 18 YEARS OF AGE OR OLDER. THE ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY IS A NON-INVASIVE ALTERNATIVE METHOD FOR PATIENT WITH SYMPTOMS OF PROXIMAL PLANTAR FASCIITIS FOR 6 MONTHS OR MORE AND A HISTORY OF UNSUCCESSFUL CONSERVATIVE THERAPIES TO RELIEVE HEEL PAIN. PROXIMAL PLANTAR FASCIITIS IS DEFINED AS HEEL PAIN IN THE AREA OF THE INSERTION OF THE PLANTAR FASCIA ON THE PLANTAR CALCANEAL TUBEROSITY.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf4/P040026B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY DEVICE
- Applicant
- Medispec, Ltd.
- PMA number
- P040026
- Product code
- NBN
- Generic name
- Generator, shock-wave, for pain relief
- Decision date
- 2005-04-01
- Decision code
- APPR
- Date received
- 2004-06-04
- Approval order statement
- APPROVAL FOR THE ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY DEVICE. THE DEVICE IS INDICATED FOR THE TREATMENT OF PROXIMAL PLANTAR FASCIITIS WITH OR WITHOUT HEEL SPUR IN PATIENTS 18 YEARS OF AGE OR OLDER. THE ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY IS A NON-INVASIVE ALTERNATIVE METHOD FOR PATIENT WITH SYMPTOMS OF PROXIMAL PLANTAR FASCIITIS FOR 6 MONTHS OR MORE AND A HISTORY OF UNSUCCESSFUL CONSERVATIVE THERAPIES TO RELIEVE HEEL PAIN. PROXIMAL PLANTAR FASCIITIS IS DEFINED AS HEEL PAIN IN THE AREA OF THE INSERTION OF THE PLANTAR FASCIA ON THE PLANTAR CALCANEAL TUBEROSITY.