510(k) · Cleared
ClearedWireless TENS/EMS, Bruno, Aela
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zmi Elecronics, Ltd. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Sep 1, 2022 as substantially equivalent to K161453 (Well-Life Healthcare Limited, 2016) and 2 other predicates after a 150-day review. Its family tree reaches back 4 generations to 2013.
- Decided
- Sep 1, 2022
- Review
- 150 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K130802 (2013). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK130802 Otc Electrical Stimulator (MT9001), Otc Tens Device (LT3060)Shenzhen Dongdixin Technology Co., Ltd. · 2013
- 3 generations backK151035 PulseReliefPhilips Consumer Lifestyle · 2015
- 2 generations backK172079 AvailOmron Healthcare, Inc. · 2017
- 1 generation backK183215 Focus TENS Therapy, Model PM710-M/-LOmron Healthcare, Inc. · 2019
- This deviceK220997 Wireless TENS/EMS, Bruno, AelaZmi Elecronics, Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K130802 | Otc Electrical Stimulator (MT9001), Otc Tens Device (LT3060) | Shenzhen Dongdixin Technology Co., Ltd. | 2013 | — |
| −3 | K151035 | PulseRelief | Philips Consumer Lifestyle | 2015 | — |
| −2 | K172079 | Avail | Omron Healthcare, Inc. | 2017 | — |
| −1 | K183215 | Focus TENS Therapy, Model PM710-M/-L | Omron Healthcare, Inc. | 2019 | — |
| 0 (this device) | K220997 | Wireless TENS/EMS, Bruno, Aela | Zmi Elecronics, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 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? (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 |
|---|---|---|---|
| * | K161453 | WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605ASummary page 4…ulator for pain relief Regulatory Class: Class II Product Code: NUH Subsequent Product Code: NGX, NYN 3. Predicate device Primary Predicate 510K Number: K161453 Device Name: Well Life Wireless TENS/EMS Stimulator, Models WR-2605A/2605 Regulation Number: 21 CFR 882.5890 Classificat… | 2016 |
| * | K183215 | Focus TENS Therapy, Model PM710-M/-LSummary page 4…trical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Subsequent Product Code: NGX, NYN Secondary Predicate 510K Number: K183215 Device Name: Focus TENS Therapy, Model PM710-M/-L Regulation Number: 21 CFR 882.5890 Classification Name: Transcutaneous… | 2019 |
| * | K183110 | LIVIASummary page 5…Page 1 of 16 Regulatory Class: Class II Product Code: NUH Subsequent Product Code: NYN Third Predicate 510K Number: K183110 Trade/Device Name: Livia Regulation Number: 21 CFR 882.5890 Classification Name: Transcutaneous electrical nerve stimula… | 2020 |
| † | K153224 | VitalStim (R) Plus Electrotherapy System | 2016 |
| † | K172876 | PowerDot PD-01M | 2017 |
| † | K020803 | Cefar Medical AB Cefar Primo | 2002 |
| † | K180865 | ZMI Self-Adhesive Electrodes | 2018 |
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 9 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- None of the 7 ancestors has a recall.
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. 2022, 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?
TENS: [RS-18, RS-28, RS-38 models]: For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. [RS-18, RS-38 models]: For temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medications. [RS-18, RS-28 models]: It is also intended for…
Read the full statement (109 words)
TENS:
[RS-18, RS-28, RS-38 models]: For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
[RS-18, RS-38 models]: For temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medications.
[RS-18, RS-28 models]: It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
EMS:
[RS-18, RS-28 models]: To stimulate healthy muscles in order to improve and facilitate muscle performance.
Environments of Use: Clinics, hospital and home environments (over-the-counter)
Patient Population: Adult
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220997 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220997: Wireless TENS/EMS, Bruno, Aela.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220997
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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