510(k) · Cleared
ClearedCP Relief Wand Rx - TENS/NMES
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
N & C Holdings, LLC · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Aug 15, 2025 as substantially equivalent to K133779 (Mid-America Medical Innovations, LLC, 2014) and 1 other predicate after a 29-day review. Its family tree reaches back 7 generations to 2001.
- Decided
- Aug 15, 2025
- Review
- 29 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K010782 (2001). 29 ancestors in all, the oldest K870947 (1987). No later device cites it as a predicate yet.
- Root · 7 generations backK010782 Transamerican TensTransamerica Medical Systems · 2001
- 6 generations backK020749 Digital Transcutaneous Electrical Nerve Stimulator, Model EV-803…Everyway Medical Instruments Co.,Ltd · 2002
- 5 generations backK071951 Comfy Series: EV-804, EV-805 & EV-806Everyway Medical Instruments Co.,Ltd · 2007
- 4 generations backK082514 Tens/Ems Combo, Ems, TensMedihightec Medical Co., Ltd. · 2008
- 3 generations backK100117 LT3000 Combo Stimulator, LT3001 Tens Stimulatory, LT3002 Ems…Shenzhen Dongdixin Technology Co., Ltd. · 2010
- 2 generations backK102014 Tens Stimulator, Models 2800 and 3000Koalaty Products, Inc. · 2010
- 1 generation backK133779 CP Relief WandMid-America Medical Innovations, LLC · 2014
- This deviceK252236 CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K010782 | Transamerican Tens | Transamerica Medical Systems | 2001 | — |
| −6 | K020749 | Digital Transcutaneous Electrical Nerve Stimulator, Model EV-803 Digital Tens | Everyway Medical Instruments Co.,Ltd | 2002 | — |
| −5 | K071951 | Comfy Series: EV-804, EV-805 & EV-806 | Everyway Medical Instruments Co.,Ltd | 2007 | — |
| −4 | K082514 | Tens/Ems Combo, Ems, Tens | Medihightec Medical Co., Ltd. | 2008 | — |
| −3 | K100117 | LT3000 Combo Stimulator, LT3001 Tens Stimulatory, LT3002 Ems Stimulator | Shenzhen Dongdixin Technology Co., Ltd. | 2010 | — |
| −2 | K102014 | Tens Stimulator, Models 2800 and 3000 | Koalaty Products, Inc. | 2010 | — |
| −1 | K133779 | CP Relief Wand | Mid-America Medical Innovations, LLC | 2014 | — |
| 0 (this device) | K252236 | CP Relief Wand Rx - TENS/NMES | N & C Holdings, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2024 | 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 GZJ? 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 GZJ device
- #1 K252767 actiTENS miniscore 13.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K133779 | CP Relief WandSummary page 5…imulator, Nerve, Transcutaneous, For Pain Relief (21 CFR 882.5890) Regulatory Class: II Product Code: GZJ, IPF III. PREDICATE DEVICES CP Relief Wand ® Model CP-1000, K133779 Unipro (K-UNIPRO-US), K232441 IV. DEVICE DESCRIPTION The CP Relief Wand Rx - TENS/NMES® (“Wand”) is a multitherapy medical dev… | 2014 |
| * | K232441 | Unipro (K-UNIPRO-US)Summary page 5…, For Pain Relief (21 CFR 882.5890) Regulatory Class: II Product Code: GZJ, IPF III. PREDICATE DEVICES CP Relief Wand ® Model CP-1000, K133779 Unipro (K-UNIPRO-US), K232441 IV. DEVICE DESCRIPTION The CP Relief Wand Rx - TENS/NMES® (“Wand”) is a multitherapy medical device that combines the treatment… | 2024 |
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 24 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 29 ancestors have a recall of any class.
How does its category compare?
All GZJ devicesGZJ Stimulator, Nerve, Transcutaneous, For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · GZJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZJ
207in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZJ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZJ
13in 2025
MAUDE reports naming product code GZJ, 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 | 13 | 223 | 4 | 4 |
| 2008 | 11 | 136 | 1 | 45 |
| 2009 | 16 | 155 | 0 | 17 |
| 2010 | 5 | 232 | 0 | 22 |
| 2011 | 5 | 168 | 1 | 22 |
| 2012 | 12 | 154 | 0 | 20 |
| 2013 | 2 | — | 0 | 10 |
| 2014 | 4 | 344 | 0 | 23 |
| 2015 | 3 | 202 | 0 | 18 |
| 2016 | 3 | 163 | 0 | 32 |
| 2017 | 3 | 113 | 0 | 58 |
| 2018 | 2 | — | 0 | 21 |
| 2019 | 3 | 156 | 0 | 7 |
| 2020 | 4 | 183 | 0 | 10 |
| 2021 | 3 | 231 | 0 | 5 |
| 2022 | 4 | 175 | 0 | 4 |
| 2023 | 1 | — | 0 | 39 |
| 2024 | 3 | 207 | 0 | 12 |
| 2025 | 1 | — | 0 | 13 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
As a TENS device, the CP Relief Wand Rx - TENS/NM ES is intended for use as an adjunctive therapy for pain management for medical purposes such as symptomatic relief of chronic intractable pain and relief of acute post surgical and post-traumatic pain.
As an EMS device, the CP Relief Wand Rx - TENS/NM ES is intended for use for relaxation of muscle spasm, increasing local blood circulation, muscle re-education, prevention or retardation of disuse atrophy, prevention of venous thrombosis of the calf muscles immediately after surgery, and maintaining on increasing range of motion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252236 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252236: CP Relief Wand Rx - TENS/NMES.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252236
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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