510(k) · Cleared
ClearedRelieforMe TENS/EMS Device Model UPK-GE01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Umeheal, Ltd. · IPF Stimulator, Muscle, Powered
Cleared on Dec 23, 2019 as substantially equivalent to K162517 (Jkh Health Co., Ltd., 2017) and 1 other predicate after an 87-day review. Its family tree reaches back 6 generations to 1991. 1 later device descends from it.
- Decided
- Dec 23, 2019
- Review
- 87 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K912178 (1991). 17 ancestors in all, the oldest K880042 (1988). 1 later device descends from it, 1 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 deviceK192733 RelieforMe TENS/EMS Device Model UPK-GE01Umeheal, Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK220738 Motive Knee WrapCymedica Orthopedics, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K220738Motive Knee WrapCymedica Orthopedics, Inc. · 2022 · cites it directly0descendants
View 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) | K192733 | RelieforMe TENS/EMS Device Model UPK-GE01 | Umeheal, Ltd. | 2019 | — |
| +1 | K220738 | Motive Knee Wrap | Cymedica Orthopedics, Inc. | 2022 | — |
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 |
| 2005 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K172933 | Mini TENS DEVICE (Model KRES102), TENS & EMS DEVICE (Model KRES100B) Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 4…ology 5. Legally Marketed Predicate Device(s) Device name: Mini TENS DEVICE (Model KRES102), TENS & EMS DEVICE (Model KRES100B) Model: KRES100B 510(k) number: K172933 Manufacturer: Shenzhen Conree Technology Co.,Ltd Device name: Electronic Pulse Stimulator 510(k) number: K162517 Man… | |
| * | K162517 | Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13Summary page 4…KRES100B) Model: KRES100B 510(k) number: K172933 Manufacturer: Shenzhen Conree Technology Co.,Ltd Device name: Electronic Pulse Stimulator 510(k) number: K162517 Manufacturer: JKH Health Co., Ltd. Page 1 of 10 Device na… | 2017 |
| * | K151035 | PulseReliefSummary page 5…162517 Manufacturer: JKH Health Co., Ltd. Page 1 of 10 Device name: Pulserelief 510(k) number: K151035 Manufacturer: PHILIPS CONSUMER LIFESTYLE Reference devices: Device name: JIAJIAN self-adhesive electrode 510(k) num… | 2015 |
| † | K090198 | Jiajian Self-Adhesive Electrode | 2009 |
| † | K940954 | Synaptic 3000 | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220738 | Motive Knee Wrap | 2022 | 0 |
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 28 years and passes through 7 companies; a new generation was cleared every 4.3 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K220738 (Cymedica Orthopedics, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K162517.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
TENS: 1. It is intended for temporary relief of pain associated with sore and aching muscles in the shoulder, neck, back, waist, abdomen, lower extremities (legs), upper extremities (arms) due to strain from exercise or normal household and work activities. 2. It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. EMS: 3. To stimulate healthy muscles to improve and facilitate…
Read the full statement (134 words)
TENS:
1. It is intended for temporary relief of pain associated with sore and aching muscles in the shoulder, neck, back, waist,
abdomen, lower extremities (legs), upper extremities (arms) due to strain from exercise or normal household and work
activities.
2. It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with
arthritis.
EMS:
3. To stimulate healthy muscles to improve and facilitate muscle performance. To be used for the improvement of muscle
tone and firmness, and for strengthening muscles in the intended areas on the body.
4. To be used for relaxation of muscle spasm, increase of blood flow circulation, prevention or retardation of disuse
atrophy, muscle re-education, maintaining or increasing range of motion, and immediate post-surgical stimulation of calf
muscles to prevent venous thrombosis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K192733 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192733: RelieforMe TENS/EMS Device Model UPK-GE01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192733
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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