510(k) · Cleared
ClearedElectronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Leqing Medical Instrument Co., Ltd. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on May 8, 2023 as substantially equivalent to K211942 (Shenzhen Osto Technology Company Limited, 2021) and 1 other predicate after a 175-day review. Its family tree reaches back 9 generations to 1994.
- Decided
- May 8, 2023
- Review
- 175 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K940301 (1994). 36 ancestors in all, the oldest K880042 (1988). No later device cites it as a predicate yet.
- Root · 9 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 5 generations between
- 3 generations backK160115 Heat Pain ProOmron Healthcare, Inc. · 2016
- 2 generations backK190783 Health Expert Electronic Stimulator (model: AST-300L)Shenzhen Osto Technology Company Limited · 2020
- 1 generation backK211942 Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623…Shenzhen Osto Technology Company Limited · 2021
- This deviceK223428 Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A…Shenzhen Leqing Medical Instrument Co., Ltd. · 2023
Show all 9 generations
- Root · 9 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 8 generations backK011880 Compex SportCompex S.A. · 2002
- 7 generations backK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- 6 generations backK102598 HI-Dow-XPHi-Dow International, Inc. · 2011
- 5 generations backK121757 HealthmateforeverHealthmate International, LLC · 2012
- 4 generations backK141978 Maxpower ReliefOmron Healthcare, Inc. · 2014
- 3 generations backK160115 Heat Pain ProOmron Healthcare, Inc. · 2016
- 2 generations backK190783 Health Expert Electronic Stimulator (model: AST-300L)Shenzhen Osto Technology Company Limited · 2020
- 1 generation backK211942 Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623…Shenzhen Osto Technology Company Limited · 2021
- This deviceK223428 Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A…Shenzhen Leqing Medical Instrument Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −8 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −7 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| −6 | K102598 | HI-Dow-XP | Hi-Dow International, Inc. | 2011 | — |
| −5 | K121757 | Healthmateforever | Healthmate International, LLC | 2012 | — |
| −4 | K141978 | Maxpower Relief | Omron Healthcare, Inc. | 2014 | — |
| −3 | K160115 | Heat Pain Pro | Omron Healthcare, Inc. | 2016 | — |
| −2 | K190783 | Health Expert Electronic Stimulator (model: AST-300L) | Shenzhen Osto Technology Company Limited | 2020 | — |
| −1 | K211942 | Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) | Shenzhen Osto Technology Company Limited | 2021 | — |
| 0 (this device) | K223428 | Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A… | Shenzhen Leqing Medical Instrument Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K211942 | Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)Summary page 4…Regulatory Class: II Product Code: NUH, IRT Regulation Number: 21 CFR 882.5890 III. Predicate Device Primary Predicate device: 510(k) number: K211942 Manufacturer: Shenzhen OSTO Technology Company Limited Trade name: Heating Lumbar Therapy Cushion/AST-622 Product… | 2021 |
| * | K190783 | Health Expert Electronic Stimulator (model: AST-300L)Summary page 4…name: Heating Lumbar Therapy Cushion/AST-622 Product code: NGX, NUH, IRT Approval date: December 13, 2021 Secondary predicate device: 510(k) number: K190783 Manufacturer: Shenzhen OSTO Technology Company Limited Trade name: Health Expert Electronic Stimulator/AST-300L Pr… | 2020 |
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 29 years and passes through 8 companies; a new generation was cleared every 2.0 years on median.
- None of the 36 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. 2023, 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?
Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B: Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of neck, arm, and leg, due to strain from exercise or normal household and work activities. Notel: The electrode on the stimulator is used in the waist. Note2: The additional gel patch is used in shoulder, waist, back, back of neck, arm, and leg.…
Read the full statement (137 words)
Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B:
Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder,
waist, back, back of neck, arm, and leg, due to strain from exercise or normal household and work activities.
Notel: The electrode on the stimulator is used in the waist.
Note2: The additional gel patch is used in shoulder, waist, back, back of neck, arm, and leg.
Heating: To be used for temporary relief of minor aches and pains.
Models: uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A,
LQ-9535A: Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the
back of neck, due to strain from exercise or normal household and work activities.
Heating: To be used for temporary relief of minor aches and pains.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223428 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223428: Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223428
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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