510(k) K202113
- Device
- Ceragem Automatic Thermal Massager, Model CGM-MB-1901
- Applicant
- Ceragem Co, Ltd.
- 510(k) number
- K202113
- Product code
- JFB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-03-02
- Date received
- 2020-07-30
- Regulation
- 890.5880
- Classification name
- Table, Physical Therapy, Multi Function
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Hyeonggeun Hwang
- Address
- 10, Jeongja 1-Gil, Seonggeo-Eup, Seobuk-Gu Chennan-Si KR 31041 31041
FDA Registration Numbers#
- 3002849858
- 1931814
- 3004006265
- 3004755153
- 3025488993
- 1415746
- 2510425
Source Documents#
Other 510(k) Records For Product Code JFB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250266 | Ceragem Automatic Thermal Massager (CGM MB-2401) | Ceragem Co., Ltd. | 2025-07-11 |
| K241193 | AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.) | Marzzan Lucas Jorge | 2025-01-31 |
| K243644 | Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302) | Ceragem Co., Ltd. | 2025-01-08 |
| K243355 | Ceragem Automatic Thermal Massager (CGM-MB-1902) | Ceragem Co., Ltd. | 2024-11-27 |
| K240168 | N7-S | Nuga Medical Co., Ltd. | 2024-09-12 |
| K220572 | Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702 | Ceragem Co., Ltd. | 2022-06-17 |
| K202937 | Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702 | Ceragem Co., Ltd. | 2021-03-18 |
| K153054 | N5-1 | Nuga Medical Co., Ltd. | 2016-02-05 |
| K140592 | CERAGEM AUTOMATIC THERMAL MASSAGER | Ceragem International, Inc. | 2014-12-17 |
| K111588 | LEGACY-500 | Mt Tables, LLC | 2012-10-26 |
| K111941 | CHOYANG THERMAL MASSAGER | Choyang Medical Instrument Co., Ltd. | 2012-05-25 |
| K102938 | ACQPOINT THERMAJADE MASSAGE TABLE | Acqpoint, Inc. | 2011-09-23 |
| K111329 | NM-7000 | Nuga Medical Co., Ltd. | 2011-09-06 |
| K102281 | THERMAL MASSAGE BED, MODEL 2D-GX | Inarex Corporation | 2010-12-22 |
| K092731 | VIBRO-TRAC | Pneumex, Inc. | 2010-06-10 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases