# K024181: Prizm Medical, Inc. Micro-Z Stimulation System

- Pathway: 510(k) (Traditional)
- Applicant: Prizm Medical, Inc.
- Decided: Jun 26, 2003 after 189 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.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices 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) Empi Focus: named in the summary without a submission number

## Most influential descendants
- K032239: Thera-Cream, Model TCT004 (2004), 3 descendants of its own
- K161654: NuFACE Gel Primer (2016), 2 descendants of its own
- K243749: Jmoon Conductive Gel (2025), 0 descendants of its own
- K220735: Avologi Gel Primer (Model: Av25) (2023), 0 descendants of its own

## Indications for use
The Prizm Medical, Inc. Micro-ZTM Stimulation System is intended for 1. Transcutaneous Electrical Nerve Stimulation for the symptomatic relief and management of chronic (long-term) intractable (not easily controlled) pain and to help with the management of post surgical and post-traumatic acute pain problems. 2. Neuromuscular Electrical Stimulation for the purposes of relaxation of muscle spasm, prevention or retardation of disuse muscle atrophy, muscle re-education, increase local blood circulation, maintain or increase range of motion, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

Source page: https://510kreport.com/device/K024181
Methodology: https://510kreport.com/methodology