# K013532: Ultrastim Kit

- Pathway: 510(k) (Traditional)
- Applicant: Axelgaard Mfg. Co., Ltd.
- Decided: Aug 22, 2002 after 309 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.
7 later devices descend from it; 3 cite it directly.
0 of 8 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
- K082190: Baxolve XP Conductive Garment Accessory & Lumbar Support Kit, Models 297, 298 (2009), 4 descendants of its own
- K091317: Lumbofix Conductive Garment, Model 420 Back (2009), 2 descendants of its own
- K133502: 5000Z Firefly System (2014), 0 descendants of its own
- K112934: Neurotech Recovery (2012), 0 descendants of its own
- K102614: Avivafix Conductive Garment-Knee/Shoulder/Upper Back, Type 40 (2011), 0 descendants of its own

## Indications for use
The UltraStim Kit is intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

Source page: https://510kreport.com/device/K013532
Methodology: https://510kreport.com/methodology