DeviceClearance

Product code NGX— Physical Medicine

CoolTone

Classification name
Stimulator, Muscle, Powered, For Muscle Conditioning
Device class
Class 2
Regulation
21 CFR 890.5850
Advisory panel
Physical Medicine
Total cleared
163
First cleared
Most recent

FDA classification definition

“A powered muscle stimulator for muscle conditioning is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatigue resistance. Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this device is not intended for use in patients with medical conditions and is intended only for muscle conditioning purposes.”

— U.S. Food and Drug Administration, device classification record for product code NGX under 21 CFR 890.5850, via openFDA

Market context for product code NGX

FDA has cleared 163 devices under product code NGX between 2001 and 2026, filed by 94 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code NGX

Recent clearances under product code NGX

1–100 of 163

Data sourced from openFDA. This site is unofficial and independent of the FDA.