# K033174: BMLS03-3

- Pathway: 510(k) (Traditional)
- Applicant: Biomedical Life Systems, Inc.
- Decided: Jun 30, 2004 after 273 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BMLS02-5: named in the summary without a submission number
- (no number) BMLS03-1: named in the summary without a submission number

## 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/K033174
Methodology: https://510kreport.com/methodology