# K231569: ManaFlexx 2 (model: MF002-RX, MF002-OTC)

- Pathway: 510(k) (Traditional)
- Applicant: Manamed, Inc.
- Decided: Nov 3, 2023 after 156 days
- Product code: NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K881114 (1988). 51 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191151: JKH Stimulator Plus, Jkh USA, LLC (2019) Summary page 7.

## Most influential descendants
- K243613: Patch-TEA (Model TRI-21) (2025), 0 descendants of its own

## Indications for use
For Over-The-Counter Use: TENS: ManaFlexx 2 (MF002-OTC) is used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities. ManaFlexx 2 (MF002-OTC) is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. PMS/NMES: ManaFlexx2 (MF002-OTC) is used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases. ManaFlexx2 (MF002-OTC) is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities. For Prescription Use: TENS: ManaFlexx2 (MF002-RX) is intended for the following use: - Symptomatic relief and management of chronic, intractable pain - Adjunctive treatment for post-surgical and post-trauma acute pain - Relief of pain associated with arthritis PMS/NMES: ManaFlexx2 (MF002-RX) is intended for the following use: - Temporary relaxation of muscle spasm - Prevention or retardation of disuse atrophy - Muscle re-education - Maintaining or increasing range of motion - Increase of local blood flow in the treatment area - Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles

Source page: https://510kreport.com/device/K231569
Methodology: https://510kreport.com/methodology