NYZClass II

Stimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning

21 CFR 890.5850 / Physical Medicine

NYZ is the FDA product code for Stimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning, a class II device type, regulated under 21 CFR 890.5850. FDA's definition for this code reads: "Used for muscle stimulation for muscle conditioning. Device repeatedly contracts muscles by passing pulsed electrical current through cutaneous electrodes and into the body. Temporarily affects the stimulated muscles contractile properties, force output, and/or fatigue resistance. Not intended to be used for medical...". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: NYZ
Device name: Stimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning
FDA definition: Used for muscle stimulation for muscle conditioning. Device repeatedly contracts muscles by passing pulsed electrical current through cutaneous electrodes and into the body. Temporarily affects the stimulated muscles contractile properties, force output, and/or fatigue resistance. Not intended to be used for medical purposes (e.g., rehabilitation), for aesthetic purposes (e.g., changing the physical appearance of the muscle or body), or for the purpose of improving athletic performance.
Regulation: 21 CFR 890.5850
Device class: Class II
Review panel: Physical Medicine
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NYZ.

Recent clearances

Product code NYZ

FDA records hold no clearances under product code NYZ.

Recent recalls

Product code NYZ

FDA records show no recalls under product code NYZ.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)