Product code IPO

Device name

Orthosis, Pneumatic Structure, Rigid

Medical specialty

Physical Medicine

Device class

3

Regulation number

890.3610

Review panel

PM

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

Call for PMAs to be filed by 12/26/96 per 61 FR 50711 on 9/27/96

Source

FDA openFDA device classification dataset