Stimulator, Muscle, Powered, For Muscle Conditioning
NGX is the FDA product code for Stimulator, Muscle, Powered, For Muscle Conditioning, a class II device type, regulated under 21 CFR 890.5850. FDA's definition for this code reads: "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...". As of , FDA records hold 163 510(k) clearances under this code, the most recent dated , and 3 recalls.
Classification record
- Product code
- NGX
- Device name
- Stimulator, Muscle, Powered, For Muscle Conditioning
- FDA 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.
- 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
- 163
- Ingested recalls
- 3
Clearances, product code NGX
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2002 | 3 |
| 2003 | 2 |
| 2004 | 1 |
| 2005 | 1 |
| 2007 | 7 |
| 2008 | 3 |
| 2009 | 4 |
| 2010 | 6 |
| 2011 | 5 |
| 2012 | 3 |
| 2013 | 6 |
| 2014 | 6 |
| 2015 | 9 |
| 2016 | 4 |
| 2017 | 10 |
| 2018 | 6 |
| 2019 | 14 |
| 2020 | 11 |
| 2021 | 12 |
| 2022 | 6 |
| 2023 | 12 |
| 2024 | 12 |
| 2025 | 15 |
| 2026 | 4 |
Applicants with the most clearances
Product code NGX| Applicant | Clearances |
|---|---|
| Bio-Medical Research, Ltd. | 15 |
| Zimmer Medizinsysteme GmbH | 6 |
| Actegy Ltd. | 5 |
| Changsha Anxiang Medical Technology Co., Ltd | 5 |
| Sport-Elec | 5 |
| BTL Industries, Inc | 4 |
| DJO, LLC | 4 |
| Guangzhou Xinbo Electronic Co., Ltd | 4 |
| Johari Digital Healthcare, Ltd. | 4 |
| Well Brain International, Ltd. | 4 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.