# K133502: 5000Z Firefly System

- Pathway: 510(k) (Special)
- Applicant: Prizm Medical, Inc.
- Decided: Dec 3, 2014 after 384 days
- Product code: NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter)
- 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: 6 generations back to K912178 (1991). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033122: 5000Z System (Otc), Prizm Medical, Inc. (2004) Summary page 4.
- K013532: Ultrastim Kit, Axelgaard Mfg. Co., Ltd. (2002) Summary page 4.
- K120500: The Pain Pilot (a.K.a Pain Pilot), Hollywog, LLC (2012) Summary page 4.
- K110068: Model PM3030, Omron Healthcare, Inc. (2011) Summary page 4.

## Indications for use
To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (e.g., arm and/or leg) and lower back due to strain from exercise or normal household and work activities.

Source page: https://510kreport.com/device/K133502
Methodology: https://510kreport.com/methodology