PMA P040039
- Device
- ORBASONE PAIN RELIEF SYSTEM
- Applicant
- Orthometrix, Inc.
- PMA number
- P040039
- Product code
- NBN
- Decision date
- 2005-08-10
- Classification
- Orthopedic
- Generic name
- Generator, shock-wave, for pain relief
- Approval order statement
- APPROVAL FOR THE ORBASONE PAIN RELIEF SYSTEM. THE DEVICE IS INDICATED FOR EXTRACORPOREAL SHOCK WAVE THERAPY FOR THE TREATMENT OF CHRONIC PROXIMAL PLANTAR FASCIITIS IN PATIENTS 18 YEARS OF AGE OR OLDER THAT HAVE FAILED TO RESPOND TO CONSERVATIVE THERAPY. CHRONIC PROXIMAL PLANTAR FASCIITIS IS DEFINED AS HEEL PAIN IN THE AREA OF THE INSERTION OF THE PLANTAR FASCIA ON THE MEDIAL CALCANEAL TUBEROSITY THAT HAS PERSISTED FOR SIX MONTHS OR MORE.
Current openFDA PMA Record#
- Device
- ORBASONE PAIN RELIEF SYSTEM
- Applicant
- Orthometrix, Inc.
- PMA number
- P040039
- Product code
- NBN
- Generic name
- Generator, shock-wave, for pain relief
- Decision date
- 2005-08-10
- Decision code
- APWD
- Date received
- 2004-09-14
- Approval order statement
- APPROVAL FOR THE ORBASONE PAIN RELIEF SYSTEM. THE DEVICE IS INDICATED FOR EXTRACORPOREAL SHOCK WAVE THERAPY FOR THE TREATMENT OF CHRONIC PROXIMAL PLANTAR FASCIITIS IN PATIENTS 18 YEARS OF AGE OR OLDER THAT HAVE FAILED TO RESPOND TO CONSERVATIVE THERAPY. CHRONIC PROXIMAL PLANTAR FASCIITIS IS DEFINED AS HEEL PAIN IN THE AREA OF THE INSERTION OF THE PLANTAR FASCIA ON THE MEDIAL CALCANEAL TUBEROSITY THAT HAS PERSISTED FOR SIX MONTHS OR MORE.