Ceragem Automatic Thermal Massager (CGM MB-2401)
FDA 510(k) K250266 · Ceragem Co., Ltd.
510(k) numberK250266
Submission
- Device name
- Ceragem Automatic Thermal Massager (CGM MB-2401)
- Applicant
- Ceragem Co., Ltd.
Cheonan-Si, KR - Received
- January 30, 2025
- Decision date
- July 11, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JFB – Table, Physical Therapy, Multi Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5880
- Specialty
- Physical Medicine
Other 510(k)s with product code JFB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241193 | AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)JFB · Traditional | Marzzan Lucas Jorge | 01/31/2025SE |
| K243644 | Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)JFB · Special | Ceragem Co., Ltd. | 01/08/2025SE |
| K243355 | Ceragem Automatic Thermal Massager (CGM-MB-1902)JFB · Special | Ceragem Co., Ltd. | 11/27/2024SE |
| K240168 | N7-SJFB · Traditional | Nuga Medical Co., Ltd. | 09/12/2024SE |
| K220572 | Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702JFB · Traditional | Ceragem Co., Ltd. | 06/17/2022SE |
| K202937 | Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702JFB · Traditional | Ceragem Co., Ltd. | 03/18/2021SE |
| K202113 | Ceragem Automatic Thermal Massager, Model CGM-MB-1901JFB · Traditional | Ceragem Co., Ltd. | 03/02/2021SE |
| K153054 | N5-1JFB · Traditional | Nuga Medical Co., Ltd. | 02/05/2016SE |
| K140592 | Ceragem Automatic Thermal MassagerJFB · Traditional | Ceragem International, Inc. | 12/17/2014SE |
| K111588 | LEGACY-500JFB · Traditional | Mt Tables, LLC | 10/26/2012SE |
More from Mt Tables, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K243644 | Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)JFB · Special | 01/08/2025SE |
| K243355 | Ceragem Automatic Thermal Massager (CGM-MB-1902)JFB · Special | 11/27/2024SE |
| K220572 | Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702JFB · Traditional | 06/17/2022SE |
| K202937 | Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702JFB · Traditional | 03/18/2021SE |
| K202113 | Ceragem Automatic Thermal Massager, Model CGM-MB-1901JFB · Traditional | 03/02/2021SE |
| K040031 | Ceragem-C Thermal Acupressure MassagerJFB · Traditional | 07/28/2004SE |
Questions and answers
When was Ceragem Automatic Thermal Massager (CGM MB-2401) cleared by the FDA?
Ceragem Automatic Thermal Massager (CGM MB-2401) (K250266) received a 510(k) decision of Substantially Equivalent on July 11, 2025, 162 days after the submission was received.
What is the product code of K250266?
The FDA product code is JFB – Table, Physical Therapy, Multi Function, a Class II (moderate risk) device regulated under 21 CFR 890.5880.