510(k) K262788

Device

Nova HD+

Applicant

Aura Wellness, LLC

510(k) number

K262788

Product code

SGT

Decision

Substantially Equivalent (SESE)

Decision date

2026-08-31

Date received

2026-08-06

Regulation

890.5850

Classification name

Electromagnetic Stimulator For Healthy Muscle Stimulation

Medical specialty

Physical Medicine

Review panel

Physical Medicine

Device class

2

Clearance type

Special

Statement or summary

Summary

Third party reviewed

N