510(k) · Decided
Decided5000Z System (Otc)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prizm Medical, Inc. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Aug 25, 2004 after a 330-day review. The FDA summary names its predicate without a number. 158 later devices descend from it.
- Decided
- Aug 25, 2004
- Review
- 330 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 0
158 later devices descend from it, 7 citing it directly.
- This deviceK033122 5000Z System (Otc)Prizm Medical, Inc. · 2004
- Descendant · cites it directly · 151 of its ownK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- Descendant · cites it directly · 78 of its ownK102598 HI-Dow-XPHi-Dow International, Inc. · 2011
- Descendant · 2 generations on · 58 of its ownK112392 Hivox Biotek Inc.Hivox Biotek, Inc. · 2012
- Descendant · 2 generations on · 55 of its ownK122744 Prospera Otc Tens Electronic Pulse MassagerProspera Corporation · 2013
- Descendant · 2 generations on · 50 of its ownK110068 Model PM3030Omron Healthcare, Inc. · 2011
Showing 5 of 158 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 158 · See all- K060846Therapeutic Massage CompanionEndurance Therapeutics · 2007 · cites it directly151descendants
- K102598HI-Dow-XPHi-Dow International, Inc. · 2011 · cites it directly78descendants
- K112392Hivox Biotek Inc.Hivox Biotek, Inc. · 2012 · 2 generations on58descendants
- K122744Prospera Otc Tens Electronic Pulse MassagerProspera Corporation · 2013 · 2 generations on55descendants
- K110068Model PM3030Omron Healthcare, Inc. · 2011 · 2 generations on50descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033122 | 5000Z System (Otc) | Prizm Medical, Inc. | 2004 | — |
| +1 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| +1 | K102598 | HI-Dow-XP | Hi-Dow International, Inc. | 2011 | — |
| +2 | K112392 | Hivox Biotek Inc. | Hivox Biotek, Inc. | 2012 | — |
| +2 | K122744 | Prospera Otc Tens Electronic Pulse Massager | Prospera Corporation | 2013 | — |
| +2 | K110068 | Model PM3030 | Omron Healthcare, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 9 | 0 |
| 2014 | 15 | 0 |
| 2015 | 11 | 0 |
| 2016 | 7 | 0 |
| 2017 | 15 | 0 |
| 2018 | 8 | 0 |
| 2019 | 15 | 0 |
| 2020 | 11 | 0 |
| 2021 | 13 | 0 |
| 2022 | 11 | 0 |
| 2023 | 9 | 0 |
| 2024 | 7 | 0 |
| 2025 | 9 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NUH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NUH device
- #1 K190783 Health Expert Electronic Stimulator (model…score 15.8 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Micro-Z™ Stimulation System Named without a submission number | |
| * | — | Axelgaard Mfg. Co. UltraStim Kit Named without a submission number | |
| * | — | Woodside Biomedical ReliefBand® Named without a submission number |
What descends from it? (158)
See all 1587 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060846 | Therapeutic Massage Companion | 2007 | 151 |
| K102598 | HI-Dow-XP | 2011 | 78 |
| K090042 | Painmaster MCT Patch | 2009 | 11 |
| K091757 | Otc Tens for Arm and Leg Pain Relief, Model WL-2407 | 2010 | 6 |
| K130114 | Painmaster MCT Patch | 2013 | 5 |
| K133502 | 5000Z Firefly System | 2014 | 0 |
| K112415 | Lifecare Arm & Leg Pain Relief System | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K060846 (Endurance Therapeutics, 2007) has gone furthest, with 151 descendants of its own.
How does its category compare?
All NUH devicesNUH Stimulator, Nerve, Transcutaneous, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NUH
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NUH
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUH
No recall names NUH since 2007.
Adverse event reports per year · NUH
7in 2025
MAUDE reports naming product code NUH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 161 | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 148 | 0 | 0 |
| 2011 | 6 | 231 | 0 | 0 |
| 2012 | 6 | 170 | 0 | 0 |
| 2013 | 10 | 189 | 0 | 1 |
| 2014 | 16 | 212 | 0 | 9 |
| 2015 | 14 | 198 | 0 | 11 |
| 2016 | 13 | 145 | 0 | 13 |
| 2017 | 17 | 155 | 0 | 21 |
| 2018 | 16 | 121 | 0 | 18 |
| 2019 | 19 | 213 | 0 | 5 |
| 2020 | 14 | 147 | 0 | 8 |
| 2021 | 14 | 198 | 0 | 7 |
| 2022 | 20 | 103 | 0 | 2 |
| 2023 | 15 | 127 | 0 | 4 |
| 2024 | 20 | 90 | 0 | 7 |
| 2025 | 15 | 119 | 0 | 7 |
| 2026 | 5 | 137 | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K033122 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033122: 5000Z System (Otc).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033122
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026