# K203488: emField

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Medizinsysteme GmbH
- Decided: Feb 19, 2021 after 84 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 K952089 (1995). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160992: HPM-6000, BTL Industries, Inc. (2016) Summary page 4.

## Most influential descendants
- K240234: BTL-899MS (2024), 2 descendants of its own
- K253408: CoolTone (2026), 0 descendants of its own
- K251594: truFlex (2025), 0 descendants of its own

## Indications for use
The emField is indicated to be used for: *Relaxation of muscle spasms; *Prevention or retardation of disuse atrophy; *Increasing local blood circulation; *Muscle re-education; *Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and *Maintaining or increasing range of motion.

Source page: https://510kreport.com/device/K203488
Methodology: https://510kreport.com/methodology