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.
| Device | ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY DEVICE |
| Generic Name | Generator, Shock-wave, For Pain Relief |
| Applicant | MEDISPEC, LTD. |
| Date Received | 2004-06-04 |
| Decision Date | 2005-04-01 |
| Notice Date | 2005-06-20 |
| PMA | P040026 |
| Supplement | S |
| Product Code | NBN |
| Docket Number | 05M-0241 |
| Advisory Committee | Physical Medicine |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDISPEC, LTD. 203 Perry Parkway suite 6 gaithersburg, MD 20877 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P040026 | | Original Filing |
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NIH GUDID Devices