BEMER Classic Set, BEMER Pro-Set
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K151834 FDA 510(k)
- FDA Product Code
- NGX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5850 FDA 510(k)
- Regulation Number
- 890.5850 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BEMER Classic Set and BEMER Pro-Set are electromagnetic therapy devices designed for physical medicine applications. They deliver controlled electromagnetic field stimulation to promote microcirculation and tissue regeneration, supporting recovery and healing processes in soft tissues and joints.
These devices are supplied as reusable systems intended for clinical and home use settings. The BEMER Classic Set and BEMER Pro-Set are not single-use and require proper storage to maintain functionality. Both sets are authorized under FDA 510K clearance (K151834) and comply with the Medical Device Directive (MDD), with no third-party involvement in the review process.
Frequently asked questions
Are the BEMER Classic Set and BEMER Pro-Set designed for single-use or can they be reused?
The BEMER Classic Set and BEMER Pro-Set are not single-use devices and are explicitly labeled as reusable systems. They are intended for both clinical and home use, meaning they can be used repeatedly after proper cleaning and maintenance to ensure functionality and hygiene. Always follow manufacturer guidelines for cleaning and storage to maintain performance.
How should I store the BEMER Classic Set or BEMER Pro-Set to keep it functional?
Since these devices are reusable, proper storage is critical to preserve their functionality. The manufacturer recommends storing them in a clean, dry environment away from direct sunlight, extreme temperatures, or moisture. Avoid placing heavy objects on top of the device, and ensure the components are protected from physical damage to maintain their electromagnetic performance.
What types of electromagnetic therapy do the BEMER Classic Set and BEMER Pro-Set provide, and what are they primarily used for?
Both the BEMER Classic Set and BEMER Pro-Set deliver controlled electromagnetic field stimulation to enhance microcirculation and support tissue regeneration. They are designed for physical medicine applications, particularly to aid recovery and healing in soft tissues and joints, making them useful for conditions like muscle soreness, joint stiffness, or post-injury rehabilitation.
Are there different models or sizes available for the BEMER Classic Set and BEMER Pro-Set, and if so, how do they differ?
The provided data does not specify distinct sizes or models beyond the two primary sets: the BEMER Classic Set and the BEMER Pro-Set. While the exact differences between them (e.g., intensity, electrode configurations, or additional features) are not detailed here, the Pro-Set is likely intended for more advanced or professional use compared to the Classic Set. For precise specifications, refer to the manufacturer’s documentation or contact Bemer International AG.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K151834 | Class II | Active |
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Manufacturer
- Manufacturer
- Bemer Int. AG
- FDA Applicant
- Bemer Int AG
Sources (2)
- FDA 510(k) K151834 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026