FDA product code NGX: Stimulator, Muscle, Powered, For Muscle Conditioning
NGX is the FDA product code for stimulator, muscle, powered, for muscle conditioning. It is a Class II device, regulated under 21 CFR 890.5850 and reviewed by the Physical Medicine panel. FDA has cleared 163 510(k) submissions under NGX, 49 in the last five years, from 94 different applicants. The average 510(k) review took 207 days (median 174); 176 days on average over the last three years. FDA has posted 3 recalls for NGX devices.
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.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Device class | Class II |
| Regulation | 21 CFR 890.5850 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NGX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 10 | 203 |
| 2018 | 6 | 121 |
| 2019 | 14 | 177 |
| 2020 | 11 | 257 |
| 2021 | 12 | 240 |
| 2022 | 6 | 286 |
| 2023 | 12 | 154 |
| 2024 | 12 | 238 |
| 2025 | 15 | 139 |
| 2026 | 4 | 150 |
Compare with all 510(k) review times · Search every NGX clearance
Top NGX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bio-Medical Research, Ltd. | 13 | 2021-02-10 |
| Zimmer Medizinsysteme GmbH | 6 | 2026-01-16 |
| Changsha Anxiang Medical Technology Co., Ltd. | 5 | 2025-07-30 |
| Actegy , Ltd. | 5 | 2021-12-17 |
| Guangzhou Xinbo Electronic Co., Ltd. | 4 | 2024-05-16 |
89 more applicants have NGX clearances. See the full list in Caduvo.
Most recent NGX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253790 | Beijing Winkonlaser Technology Limited | High Intensity Focused Electromagnetic Stimulation Device (FE60) | 2026-08-13 | 258 |
| K253926 | ShenB Co., Ltd. | Diacore | 2026-04-10 | 123 |
| K253636 | Termosalud S.L. | Zionic Pro Max (EMS) | 2026-03-12 | 113 |
| K253408 | Zimmer Medizinsysteme GmbH | CoolTone | 2026-01-16 | 108 |
| K252154 | Guangzhou Longest Medical Technology Co., Ltd. | Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) | 2025-12-09 | 153 |
Recalls for NGX devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-01-13.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code NGX?
NGX is the FDA product code for stimulator, muscle, powered, for muscle conditioning. It is a Class II device, regulated under 21 CFR 890.5850 and reviewed by the Physical Medicine panel.
What device class is NGX?
Class II, regulation 21 CFR 890.5850. Typical premarket route: 510(k).
How long does a 510(k) take for product code NGX?
Across 163 cleared submissions the average was 207 days from receipt to decision (median 174).
Which companies have the most NGX clearances?
Bio-Medical Research, Ltd. (13); Zimmer Medizinsysteme GmbH (6); Changsha Anxiang Medical Technology Co., Ltd. (5); Actegy , Ltd. (5); Guangzhou Xinbo Electronic Co., Ltd. (4).
Have NGX devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2021-01-13.
Next steps
- Run an FDA pathway report with predicate devices for product code NGX
- Run a recall and safety report across every NGX manufacturer
- Watch product code NGX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Physical Medicine product codes · FDA product code lookup · 510(k) database search · 510(k) review times