N5-1
FDA 510(k) K153054 · Nuga Medical Co., Ltd.
510(k) numberK153054
Submission
- Device name
- N5-1
- Applicant
- Nuga Medical Co., Ltd.
Wonju-Si, KR - Received
- October 20, 2015
- Decision date
- February 5, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|---|
| K250266 | Ceragem Automatic Thermal Massager (CGM MB-2401)JFB · Traditional | Ceragem Co., Ltd. | 07/11/2025SE |
| 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 |
| K140592 | Ceragem Automatic Thermal MassagerJFB · Traditional | Ceragem International, Inc. | 12/17/2014SE |
| K111588 | LEGACY-500JFB · Traditional | Mt Tables, LLC | 10/26/2012SE |
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Questions and answers
When was N5-1 cleared by the FDA?
N5-1 (K153054) received a 510(k) decision of Substantially Equivalent on February 5, 2016, 108 days after the submission was received.
What is the product code of K153054?
The FDA product code is JFB – Table, Physical Therapy, Multi Function, a Class II (moderate risk) device regulated under 21 CFR 890.5880.