510(k) · Cleared
ClearedNerve and Muscle Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Xft Medical Limited · IPF Stimulator, Muscle, Powered
Cleared on Apr 11, 2020 as substantially equivalent to K082011 (Bio-Medical Research, Ltd., 2008) and 1 other predicate after a 137-day review. Its family tree reaches back 6 generations to 1991. 2 later devices descend from it.
- Decided
- Apr 11, 2020
- Review
- 137 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K912178 (1991). 18 ancestors in all, the oldest K880042 (1988). 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK912178 Bio Tens 601, 606 and 608 (3000)Skylark Device Co., Ltd. · 1991
- 5 generations backK972244 NT2000Bio-Medical Research, Ltd. · 1998
- 4 generations backK990787 TRIO 300Ito Co., Ltd. · 1999
- 3 generations backK023231 Elfcare Device, Models 314A Through 314GMediseb, Ltd. · 2003
- 2 generations backK070299 Ezfit Digital Heating Tens (Model NO.: HR-661/UC-101)Ezfit Technology, Inc. · 2007
- 1 generation backK162517 Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13Jkh Health Co., Ltd. · 2017
- This deviceK193275 Nerve and Muscle StimulatorShenzhen Xft Medical Limited · 2020
- Descendant · cites it directly · 0 of its ownK223027 NeuroTrigger Basic (NTB)Neurotrigger · 2023
- Descendant · cites it directly · 0 of its ownK201431 OGYILI TENS/NMES StimulatorGongguan Tutamen Metalwork Co., Ltd. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K912178 | Bio Tens 601, 606 and 608 (3000) | Skylark Device Co., Ltd. | 1991 | — |
| −5 | K972244 | NT2000 | Bio-Medical Research, Ltd. | 1998 | — |
| −4 | K990787 | TRIO 300 | Ito Co., Ltd. | 1999 | — |
| −3 | K023231 | Elfcare Device, Models 314A Through 314G | Mediseb, Ltd. | 2003 | — |
| −2 | K070299 | Ezfit Digital Heating Tens (Model NO.: HR-661/UC-101) | Ezfit Technology, Inc. | 2007 | — |
| −1 | K162517 | Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 | Jkh Health Co., Ltd. | 2017 | — |
| 0 (this device) | K193275 | Nerve and Muscle Stimulator | Shenzhen Xft Medical Limited | 2020 | — |
| +1 | K223027 | NeuroTrigger Basic (NTB) | Neurotrigger | 2023 | — |
| +1 | K201431 | OGYILI TENS/NMES Stimulator | Gongguan Tutamen Metalwork Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 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 IPF? 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 IPF device
- #1 K241433 EVE Synergy (EVE-20M)score 19.7 · 25 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 |
|---|---|---|---|
| * | K082011 | Medistim XP, Type 281 and Meditens XP, Type 458Summary page 6…Predicate Device Information Sponsor: Rio-Medical Research Ltd. Device: MediStim XP, Type 281; 510(K) Number: K082011 Sponsor: JKH Health Co., Ltd. Device: Electronic Pulse Stimulator 510(K) Nu… | 2008 |
| * | K162517 | Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13Summary page 6…510(K) Number: K082011 Sponsor: JKH Health Co., Ltd. Device: Electronic Pulse Stimulator 510(K) Number: K162517 5.4 Device Description Nerve and Muscle Stimulator (model: XFT-2000) is based on the principles of neuromuscular electrical st… | 2017 |
| † | K171803 | HIVOX OTC Electrical Stimulator | 2017 |
| † | K130802 | Otc Electrical Stimulator (MT9001), Otc Tens Device (LT3060) | 2013 |
| † | K153704 | Strive | 2016 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 29 years and passes through 7 companies; a new generation was cleared every 4.3 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K223027 (Neurotrigger, 2023) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K082011.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · IPF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IPF
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IPF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IPF
8in 2025
MAUDE reports naming product code IPF, 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 | 8 | 143 | 0 | 11 |
| 2008 | 6 | 140 | 1 | 213 |
| 2009 | 7 | 216 | 0 | 150 |
| 2010 | 4 | 121 | 0 | 14 |
| 2011 | 4 | 275 | 1 | 25 |
| 2012 | 4 | 269 | 3 | 16 |
| 2013 | 10 | 180 | 0 | 6 |
| 2014 | 4 | 264 | 0 | 19 |
| 2015 | 3 | 43 | 0 | 11 |
| 2016 | 7 | 113 | 0 | 8 |
| 2017 | 5 | 110 | 0 | 2 |
| 2018 | 5 | 73 | 0 | 3 |
| 2019 | 4 | 133 | 0 | 10 |
| 2020 | 9 | 121 | 0 | 13 |
| 2021 | 15 | 98 | 0 | 3 |
| 2022 | 7 | 108 | 0 | 4 |
| 2023 | 9 | 255 | 1 | 8 |
| 2024 | 7 | 201 | 0 | 5 |
| 2025 | 3 | 257 | 0 | 8 |
| 2026 | 3 | 206 | 0 | — |
What is it indicated for?
Over-The-Counter Use: TENS[ (Program 1~9, Program 15 (Frequency＜5Hz or ＞15Hz)]: XFT-2000 is used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities. XFT-2000 is also intended for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. NMES[ (Program 10~14, Program 15(5Hz≤Frequency≤50Hz)]: XFT-2000 is used to…
Read the full statement (190 words)
Over-The-Counter Use:
TENS[ (Program 1~9, Program 15 (Frequency＜5Hz or ＞15Hz)]:
XFT-2000 is used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities.
XFT-2000 is also intended for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
NMES[ (Program 10~14, Program 15(5Hz≤Frequency≤50Hz)]:
XFT-2000 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, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
XFT-2000 is also intended to temporarily increase local blood circulation in health muscles of lower extremities.
Prescription Use:
XFT-2000 is intended for the following use:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
- Adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193275 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193275: Nerve and Muscle Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193275
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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