510(k) · Cleared
ClearedNooro Body & Foot Stimulator (SM9141, SM9142)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xf Agencija Limited · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Nov 22, 2024 after a 29-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Nov 22, 2024
- Review
- 29 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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. 2024, 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?
For Over-The-Counter Use: TENS: The device (SM9141, SM9142) is used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, leg and feet, due to strain from exercise or normal household and work activities and also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. EMS/NMES: The device (SM9141, SM9142) is used to stimulate healthy…
Read the full statement (217 words)
For Over-The-Counter Use:
TENS:
The device (SM9141, SM9142) is used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, leg and feet, due to strain from exercise or normal household and work activities and also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
EMS/NMES:
The device (SM9141, SM9142) is used to stimulate healthy muscles in order to improve and facilitate muscle performance.
To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, feet and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
The device (SM9141, SM9142) is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.
For Prescription Use:
Device (SM9141, SM9142):
TENS:
- Symptomatic relief and management of chronic, intractable pain
- Adjunctive treatment for post-surgical and post-trauma acute pain
- Relief of pain associated with arthritis
EMS/NMES:
- Temporary relaxation of muscle spasm
- Prevention or retardation of disuse atrophy
- Muscle re-education
- Maintaining or increasing range of motion
- Increase of local blood flow in the treatment area
- Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K243334 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243334: Nooro Body & Foot Stimulator (SM9141, SM9142).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243334
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026