CoolTone
FDA 510(k) K192940 · Zimmer Medizinsysteme GmbH
510(k) numberK192940
Submission
- Device name
- CoolTone
- Applicant
- Zimmer Medizinsysteme GmbH
Neu-Ulm, DE - Received
- October 18, 2019
- Decision date
- November 15, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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…
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| 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 |
|---|---|---|
| K253408 | CoolToneNGX · Traditional | 01/16/2026SE |
| K251378 | CoolToneNGX · Special | 07/14/2025SE |
| K240347 | PTG-05NGX · Traditional | 07/21/2024SE |
| K240178 | RFG-01PBX · Traditional | 07/15/2024SE |
| K230780 | MFG-05KPI · Traditional | 10/05/2023SE |
| K213256 | ThermoTKPBX · Traditional | 05/25/2023SE |
| K222912 | c1TracITH · Traditional | 05/16/2023SE |
| K220601 | CoolToneNGX · Special | 04/01/2022SE |
| K220020 | Cryo 7GEX · Special | 02/04/2022SE |
| K203488 | emFieldIPF · Traditional | 02/19/2021SE |
Questions and answers
When was CoolTone cleared by the FDA?
CoolTone (K192940) received a 510(k) decision of Substantially Equivalent on November 15, 2019, 28 days after the submission was received.
What is the product code of K192940?
The FDA product code is NGX – Stimulator, Muscle, Powered, For Muscle Conditioning, a Class II (moderate risk) device regulated under 21 CFR 890.5850.