ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY DEVICE

FDA premarket approval P040026 · decided 2005-04-01

Approval details

PMA number

P040026

Trade name

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

Days to decision

301 days

Decision code

APPR

Product code

NBN

Advisory committee

Physical Medicine

Expedited review

No

Location

Gaithersburg, MD

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

510(k) clearances by this applicant