# K024036: Product Line-Combo Stimulator/Sequential Stimulator, Model IF-5000

- Pathway: 510(k) (Special)
- Applicant: Johari Digital Healthcare, Ltd.
- Decided: Dec 20, 2002 after 14 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: 2 generations back to K964028 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993229: Analgesic Pulser, Model AP-439, Johari Electro-Tech Co. (2001) Summary page 2.

## Indications for use
Combo Stimulator IF-5000 provides combination of desired stimulating currents, which can be chosen by clinicians for the following treatment therapies: INTENDED USE (A) Interferential Current Stimulation is indicated for: 1. Symptomatic relief and management of chronic, intractable pain: 2. Adjunctive treatment in the management of post-surgical and post-traumatic, acute pain conditions. (B) Electrical Muscle Stimulation (EMS or Russian) is indicated for: 1. Relaxation of Muscle spasm. 2. Prevention or Retardation of disuse atrophy. 3. Increasing local blood circulation. 4. Muscle re-education. 5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. 6. Maintaining or increasing range of motion.

Source page: https://510kreport.com/device/K024036
Methodology: https://510kreport.com/methodology