510(k) · Cleared
ClearedAvazzia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avazzia, Inc. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on May 12, 2017 as substantially equivalent to K122744 (Prospera Corporation, 2013) after a 259-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- May 12, 2017
- Review
- 259 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K940301 (1994). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 4 generations backK011880 Compex SportCompex S.A. · 2002
- 3 generations backK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- 2 generations backK102598 HI-Dow-XPHi-Dow International, Inc. · 2011
- 1 generation backK122744 Prospera Otc Tens Electronic Pulse MassagerProspera Corporation · 2013
- This deviceK162392 AvazziaAvazzia, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −4 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −3 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| −2 | K102598 | HI-Dow-XP | Hi-Dow International, Inc. | 2011 | — |
| −1 | K122744 | Prospera Otc Tens Electronic Pulse Massager | Prospera Corporation | 2013 | — |
| 0 (this device) | K162392 | Avazzia | Avazzia, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2012 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K122744 | Prospera Otc Tens Electronic Pulse MassagerSummary page 4…H Information of the 510(k) Cleared Devices (Predicate Devices): Primary Predicate: Prospera OTC TENS Electronic Pulse Massager, Models PL009, PL009A, and PL029, K122744 03/28/2013, TENS Class II 21 CFR 882.5890 NUH, NGX Reference Devices: Avazzia TENS Model BEST-AV1™, K062641, 4/30/… | 2013 |
| † | K062641 | Body-Stim, Biomodulator, Best-Rsi, Best Pro, Model Best-AV1 | 2007 |
| † | K123099 | Best-AV2 Pro-Sport (tm) | 2014 |
| † | K060222 | Low Back Pain Relief System /Models GM310PP,GM320PP,GM321PP, and GM330PP | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 23 years and passes through 6 companies; a new generation was cleared every 4.1 years on median.
- None of the 9 ancestors has a recall.
- 7 other devices also cite its predicate K122744.
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. 2017, this device’s year, is highlighted.
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?
Transcutaneous Electrical Nerve Stimulation (TENS) for the temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household 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/K162392 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162392: Avazzia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162392
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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