# K041388: Combination Powered Electrical Muscle Stimulator and Interferential Stimulator, Model BMLS04-1

- Pathway: 510(k) (Traditional)
- Applicant: Biomedical Life Systems, Inc.
- Decided: Nov 23, 2004 after 182 days
- Product code: GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K121305: Sterling Medical Impulse 3 Stimulator (2012), 0 descendants of its own

## Indications for use
Muscle Stimulator Mode: 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. Interferential Mode: Interferential Stimulation is used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of postsurgical and post-traumatic acute pain. TENS Mode: Transcutaneous Electrical Nerve Stimulation (TENS) is used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

Source page: https://510kreport.com/device/K041388
Methodology: https://510kreport.com/methodology