Extracorporeal Shock Wave Treatment

OME · Class III — High Risk (PMA approval required, life-sustaining) · Unknown

Classification

FDA Product Code: OME
Device class: Class III — High Risk (PMA approval required, life-sustaining)
Regulation: —
Review panel: OR
Medical specialty: Unknown
Submission type: 2
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

For use for extracorporeal shock wave treatment of atrophic nonunion fractures. The device delivers a shock wave to the patient via a water-filled coupling membrane whic is intented to help atrophic nonunion fractures heal.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown