# K221958: Flex-MI

- Pathway: 510(k) (Traditional)
- Applicant: Emsi, Inc.
- Decided: Oct 21, 2022 after 108 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: 3 generations back to K000114 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112348: RS-4I Muscle Stimulator, Rs Medical (2012) Summary page 4.

## Indications for use
Interferential Stimulation > Symptomatic relief of chronic intractable pain > Adjunctive treatment for the management of post-traumatic or post-surgical pain EMS (Electrical Muscle Stimulation) > Relaxation of muscle spasm > Increasing local blood circulation > Muscle re-education > Prevention or retardation of disuse atrophy > Prevention of venous thrombosis of the calf muscles immediately after surgery > Maintaining or increase range of motion

Source page: https://510kreport.com/device/K221958
Methodology: https://510kreport.com/methodology