V12 Pro
510(k) K210913
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK210913 | Date4 Aug 2021 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IRP
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5650
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The V12 Pro is a Powered Inflatable Tube Massager, classified as a Class II device under FDA regulation 890.5650. It delivers intermittent pneumatic compression to promote circulation and reduce edema, primarily used in physical medicine applications.
This device is intended for single-use or reusable clinical settings, depending on manufacturer guidelines, and is not MRI-compatible. Supplied in various sizes (as referenced by FEI numbers), it requires proper storage and handling to maintain sterility. The V12 Pro holds FDA 510(k) clearance (K210913) under the Traditional review pathway, with a decision date of August 4, 2021.
Other devices from Slk Medical GmbH
Questions
AI-generated answers, 19 Sep 2026
What clinical applications is the V12 Pro primarily designed for, and how does it work?
The V12 Pro is a Powered Inflatable Tube Massager classified under FDA regulation 890.5650, intended for physical medicine applications. It delivers intermittent pneumatic compression (IPC) to promote circulation and reduce edema (swelling) in patients. This is commonly used in post-operative recovery, chronic venous insufficiency, or lymphedema management to improve blood flow and tissue health.
Is the V12 Pro single-use or reusable, and how should I handle it to maintain sterility?
The V12 Pro is designed for both single-use and reusable clinical settings, depending on facility protocols and manufacturer guidelines. To maintain sterility, follow the manufacturer’s instructions for cleaning, disinfection, or sterilization if reused. Sterile packaging is implied for single-use applications, so ensure proper handling to avoid contamination.
What sizes or models of the V12 Pro are available, and how do I determine the right fit for a patient?
The V12 Pro comes in multiple sizes, each referenced by a unique FEI number (e.g., 3012184077, 3027321925, etc.). These sizes correspond to different limb applications (e.g., calf, thigh, or arm). The correct size depends on the patient’s anatomy—consult the manufacturer’s sizing guide or clinical documentation to match the patient’s limb circumference for optimal compression and comfort.
Can the V12 Pro be used in an MRI environment, and what storage requirements should I follow?
The V12 Pro is not MRI-compatible, meaning it should never be used in or near an MRI scanner. For storage, keep the device in a clean, dry environment away from direct sunlight or extreme temperatures. If sterile packaging is intact, adhere to single-use protocols; if reusable, follow the manufacturer’s cleaning and storage instructions to preserve functionality and hygiene.
What regulatory pathway was used for FDA clearance, and how can I verify the device’s compliance?
The V12 Pro received FDA 510(k) clearance (K210913) under the Traditional review pathway, determined to be substantially equivalent to a predicate device. The clearance was granted by the Physical Medicine (PM) advisory committee on August 4, 2021. To verify compliance, check the FDA’s OpenFDA database using the device’s registration numbers (e.g., 3012184077) or contact Slk Medical GmbH (address: Am Herdicksbach 18, Waltrop, Germany) for official documentation.