Product code PBX

Device name

Massager, Vacuum, Radio Frequency Induced Heat

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.4400

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

Definition

Generates heat in body tissues for minor relief of minor aches and pain. Mechanical massaging to provide a temporary reduction in the appearance of cellulite.

Source

FDA openFDA device classification dataset