510(k) · Cleared
ClearedTENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hivox Biotek, Inc. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Jun 16, 2026 after a 126-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jun 16, 2026
- Review
- 126 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. 2026, 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 / EMS DEVICE (FT-247 Series) (FT-247, FT-237) FT-247 (1)TENS: This function is designated to be used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. (2)EMS: This function is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle…
Read the full statement (153 words)
TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)
FT-247
(1)TENS: This function is designated to be used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
(2)EMS: This function is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle performance.
(3)Superficial heat (SH) : This function is designed to be used for temporary relief of minor aches and pains.
FT-237
(1)TENS: This function is designated to be used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
(2)EMS: This function is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle performance.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K260425 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260425: TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260425
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026