Slendertone Enervive, Model 561
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K071666 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)
Our SLENDERTONE ENERVIVE, MODEL 561 is a high-performance, FDA-approved, and clinically-tested physical therapy device for enhancing muscle recovery after exercise. This advanced device uses gentle yet effective electrical impulses to stimulate muscle contractions, promoting faster healing and greater strength gains. By combining the latest advancements in neuromuscular stimulation with traditional treatment methods, our device has been shown to improve patient outcomes while reducing recovery time. With its sleek design and user-friendly interface, this SLENDERTONE ENERVIVE, MODEL 561 is an ideal choice for professionals and patients alike seeking effective muscle conditioning solutions.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K071666 | Class II | Active |
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Manufacturer
- Manufacturer
- Bio-Medical Research Corp.
Sources (1)
- FDA 510(k) K071666 24 fields · synced Oct 6, 2026