CERAGEM AUTOMATIC THERMAL MASSAGER
FDA 510(k) clearance K140592 · decided 2014-12-17
Clearance details
- K-number
- K140592
- Device name
- CERAGEM AUTOMATIC THERMAL MASSAGER
- Applicant
- Ceragem International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-03-07
- Decision date
- 2014-12-17
- Days to decision
- 285 days
- Clearance type
- Traditional
- Product code
- JFB
- Device class
- 2
- Regulation number
- 890.5880
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Crofton, MD, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Ceragem Automatic Thermal Massager (CGM MB-2401) (K250266) | Ceragem Co., Ltd. | 2025-07-11 |
| AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.) (K241193) | Marzzan Lucas Jorge | 2025-01-31 |
| Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302) (K243644) | Ceragem Co., Ltd. | 2025-01-08 |
| Ceragem Automatic Thermal Massager (CGM-MB-1902) (K243355) | Ceragem Co., Ltd. | 2024-11-27 |
| N7-S (K240168) | Nuga Medical Co., Ltd. | 2024-09-12 |
| Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702 (K220572) | Ceragem Co., Ltd. | 2022-06-17 |
| Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702 (K202937) | Ceragem Co., Ltd. | 2021-03-18 |
| Ceragem Automatic Thermal Massager, Model CGM-MB-1901 (K202113) | Ceragem Co., Ltd. | 2021-03-02 |
| N5-1 (K153054) | Nuga Medical Co., Ltd. | 2016-02-05 |
| LEGACY-500 (K111588) | Mt Tables, LLC | 2012-10-26 |
| CHOYANG THERMAL MASSAGER (K111941) | Choyang Medical Instrument Co., Ltd. | 2012-05-25 |
| ACQPOINT THERMAJADE MASSAGE TABLE (K102938) | Acqpoint, Inc. | 2011-09-23 |
Recalls involving this device
No recalls on record reference this clearance.