# K031427: Electro Neuromuscular Stimulator, Model BMLS03-1

- Pathway: 510(k) (Traditional)
- Applicant: Biomedical Life Systems, Inc.
- Decided: Aug 19, 2003 after 105 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K063642: FD Ems, Model # D-FJ30E (2007), 1 descendant of its own
- K152676: FD Tens 2090, FD Tens 2095 (2016), 0 descendants of its own

## Indications for use
External electrical neuromuscular stimulation using biphasic output is indicated as therapeutic adjunct for: prevention or retardation of muscle disuse atrophy; relaxation of muscle spasm; muscle reeducation; maintaining and increasing the range of motion; increasing local blood circulation and as immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.

Source page: https://510kreport.com/device/K031427
Methodology: https://510kreport.com/methodology