# K210284: ManaSport

- Pathway: 510(k) (Traditional)
- Applicant: Manamed, Inc.
- Decided: Apr 26, 2022 after 448 days
- Product code: IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat)
- Device class: 2
- Regulation: 21 CFR 890.5300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K222098: ManaSport+ (2023), 1 descendant of its own
- K240788: Ultrasound Stimulator (2025), 0 descendants of its own

## Indications for use
Apply stationary use of ultrasound to: Generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation. Apply continuous movement of ultrasound for: 1. Pain. 2. Pain relief, muscle spasms, and joint contractures. 3. Relief of pain, muscle spasms, and joint contractures that may be associated with: * Adhesive capsulitis, * Bursitis with slight calcification, * Myositis, * Soft tissue injuries, and * Shortened tendons due to past injuries and scar tissues. 4. Relief of pain, muscle spasms, and joint contractures resulting from: * Capsular tightness, and * Capsular scarring. 5. Localized increase in blood flow. 6. Increased range of motion of contracted joint using heat and stretch techniques.

Source page: https://510kreport.com/device/K210284
Methodology: https://510kreport.com/methodology