# K121305: Sterling Medical Impulse 3 Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Armstrong Industries, Inc. Dha Mediquip Int. Dha S
- Decided: Sep 25, 2012 after 147 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
Longest line of descent: 2 generations back to K926510 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041388: Combination Powered Electrical Muscle Stimulator and Interferential Stimulator, Model BMLS04-1, Biomedical Life Systems, Inc. (2004) Summary page 1.
- K003631: Smartwave IF 2000, Newwave Medical, LLC (2001) Summary page 2.
- K041063: Smartwave MS 2000, Newwave Medical, LLC (2004) Summary page 1.
- K891118: Sterling Tens, Armstrong Industries, Inc. (1989) Summary page 1.

## Indications for use
Interferential Stimulation (INF) is used for symptomatic relief and management of chronic (long-term) intractable pain and/or as an adjunctive treatment in the management of postsurgical and post-traumatic acute pain. External electrical neuromuscular stimulation (NMES) 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. Transcutaneous Electrical Nerve Stimulation (TENS) is used for the symptomatic relief and management of chronic (long-term) intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain problems.

Source page: https://510kreport.com/device/K121305
Methodology: https://510kreport.com/methodology