Ion Magnum Genius
FDA 510(k) K123158 · Ion Genius, Inc.
510(k) numberK123158
Submission
- Device name
- Ion Magnum Genius
- Applicant
- Ion Genius, Inc.
Honolulu, HI, US - Received
- October 9, 2012
- Decision date
- June 21, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NGX – Stimulator, Muscle, Powered, For Muscle Conditioning
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5850
- Specialty
- Physical Medicine
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…
Other 510(k)s with product code NGX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253790 | High Intensity Focused Electromagnetic Stimulation Device (FE60)NGX · Traditional | Beijing Winkonlaser Technology Limited | 08/13/2026SE |
| K253926 | DiacoreNGX · Traditional | ShenB Co., Ltd. | 04/10/2026SE |
| K253636 | Zionic Pro Max (EMS)NGX · Traditional | Termosalud S.L. | 03/12/2026SE |
| K253408 | CoolToneNGX · Traditional | Zimmer Medizinsysteme GmbH | 01/16/2026SE |
| K252154 | Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)NGX · Traditional | Guangzhou Longest Medical Technology Co., Ltd. | 12/09/2025SE |
| K253478 | Motive Muscle Stimulator for Lower Back (OT01-1003)NGX · Traditional | Motive Health, Inc. | 11/06/2025SE |
| K251594 | truFlexNGX · Special | Syrma Johari Medtech Limited | 08/28/2025SE |
| K251706 | TENS and EMS UnitNGX · Special | Changsha Anxiang Medical Technology Co., Ltd. | 07/30/2025SE |
| K251378 | CoolToneNGX · Special | Zimmer Medizinsysteme GmbH | 07/14/2025SE |
| K251746 | Pure ImpactNGX · Special | Sofwave Medical, Ltd. | 07/02/2025SE |
More from Sofwave Medical, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K132179 | ArasysNGX · Traditional | 04/28/2014SE |
Questions and answers
When was Ion Magnum Genius cleared by the FDA?
Ion Magnum Genius (K123158) received a 510(k) decision of Substantially Equivalent on June 21, 2013, 255 days after the submission was received.
What is the product code of K123158?
The FDA product code is NGX – Stimulator, Muscle, Powered, For Muscle Conditioning, a Class II (moderate risk) device regulated under 21 CFR 890.5850.