510(k) clearance

Nova HD+

FDA 510(k) source

510(k) number

K262788

Applicant

Aura Wellness, LLC

Decision date

Aug 31, 2026

Date received

Aug 6, 2026

Decision

Substantially Equivalent

Clearance type

Special

Product code

SGT

Device type

Electromagnetic Stimulator For Healthy Muscle Stimulation

Device class

Class II

Regulation

21 CFR 890.5850

Advisory committee

Physical Medicine

Statement or summary

Summary

Third party

N

Location

Louisville, KY, US