• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 
Trade NameORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY DEVICE
Classification Namegenerator, shock-wave, for pain relief
Generic Nameorthopedic extracorporeal shock wave therapy
ApplicantMEDISPEC, LTD.
PMA NumberP040026
Date Received06/04/2004
Decision Date04/01/2005
Product Code
NBN[ Registered Establishments with NBN ]
Docket Number 05M-0241
Notice Date 06/20/2005
Advisory Committee Physical Medicine
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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.
Approval Order Approval Order
-
-