RFG-01
FDA 510(k) K240178 · Zimmer Medizinsysteme GmbH
510(k) numberK240178
Submission
- Device name
- RFG-01
- Applicant
- Zimmer Medizinsysteme GmbH
Neu-Elm, DE - Received
- January 23, 2024
- Decision date
- July 15, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PBX – Massager, Vacuum, Radio Frequency Induced Heat
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Generates heat in body tissues for minor relief of minor aches and pain. Mechanical massaging to provide a temporary reduction in the appearance of cellulite.
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253480 | Capenergy C Equipments RF C200 and C400 DrakarianPBX · Abbreviated | Capenergy Medical S.L. | 07/10/2026SE |
| K260647 | SpecchioPBX · Special | El.En S.P.A. | 04/02/2026SE |
| K253261 | Apollo Quattro (APQ-10M)PBX · Traditional | Weero Co., Ltd. | 03/13/2026SE |
| K252888 | NeoSculpt PlusPBX · Traditional | S&M Medical Co., Ltd. | 03/09/2026SE |
| K250734 | OptiLUV DevicePBX · Traditional | Pollogen, Ltd. | 09/10/2025SE |
| K250916 | WinForth (LM-E470KA)PBX · Traditional | Shenzhen Leaflife Technology Co., Ltd. | 08/14/2025SE |
| K243716 | Zionic Pro Max (Radiofrequency)PBX · Traditional | Termosalud S.L. | 05/28/2025SE |
| K241733 | Hebe (NP0000763)PBX · Traditional | Novasonix Technology S.L. | 04/16/2025SE |
| K243055 | Préime DermaFacial Collagen+PBX · Traditional | EMA Aesthetics , Ltd. | 04/15/2025SE |
| K242175 | XOD Diathermia Radiofrequency DevicePBX · Traditional | Xod, Inc. | 02/27/2025SE |
More from Xod, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253408 | CoolToneNGX · Traditional | 01/16/2026SE |
| K251378 | CoolToneNGX · Special | 07/14/2025SE |
| K240347 | PTG-05NGX · Traditional | 07/21/2024SE |
| 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 |
| K192940 | CoolToneNGX · Special | 11/15/2019SE |
Questions and answers
When was RFG-01 cleared by the FDA?
RFG-01 (K240178) received a 510(k) decision of Substantially Equivalent on July 15, 2024, 174 days after the submission was received.
What is the product code of K240178?
The FDA product code is PBX – Massager, Vacuum, Radio Frequency Induced Heat, a Class II (moderate risk) device regulated under 21 CFR 878.4400.