# K230701: Stim2Go

- Pathway: 510(k) (Traditional)
- Applicant: PAJUNK GmbH Medizintechnologie
- Decided: Nov 24, 2023 after 255 days
- Product code: IPF (Stimulator, Muscle, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K930530 (1995). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080950: Stiwell MED4, Otto Bock, Austria GmbH (2009) Summary page 5.

## Indications for use
As a powered muscle stimulator (NMES) the Stim2Go is indicated for the following conditions: • Relaxation of muscle spasm • Prevention or retardation of disuse atrophy • Increasing local blood circulation • Muscle re-education • Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis • Maintaining or increasing range of motion As a transcutaneous electrical nerve stimulator (TENS) for pain relief the Stim2Go is indicated for the following conditions: • Symptomatic relief and management of chronic (long-term), intractable pain • Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain As a biofeedback device the Stim2Go is indicated for the following condition: • Muscle re-education purposes As a functional neuromuscular stimulator, the Stim2Go is indicated for the following conditions: • Helps to relearn voluntary motor functions of the extremities The movement-based biofeedback can only be used for patients with an active range of motion (ROM) which is defined as the ability of volitional movement resulting in a change of the concerned limb inclination angle of at least 10 degrees.

Source page: https://510kreport.com/device/K230701
Methodology: https://510kreport.com/methodology