# K033122: 5000Z System (Otc)

- Pathway: 510(k) (Traditional)
- Applicant: Prizm Medical, Inc.
- Decided: Aug 25, 2004 after 330 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
No predicates in its family tree.
158 later devices descend from it; 7 cite it directly.
0 of 159 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) Micro-Z™ Stimulation System: named in the summary without a submission number
- (no number) Axelgaard Mfg. Co. UltraStim Kit: named in the summary without a submission number
- (no number) Woodside Biomedical ReliefBand®: named in the summary without a submission number

## Most influential descendants
- K060846: Therapeutic Massage Companion (2007), 151 descendants of its own
- K102598: HI-Dow-XP (2011), 78 descendants of its own
- K112392: Hivox Biotek Inc. (2012), 58 descendants of its own
- K122744: Prospera Otc Tens Electronic Pulse Massager (2013), 55 descendants of its own
- K110068: Model PM3030 (2011), 50 descendants of its own

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

Source page: https://510kreport.com/device/K033122
Methodology: https://510kreport.com/methodology