510(k) Report

510(k) · Cleared

Cleared

IQ Technologies

K131290510(k) TraditionalCleared Aug 6, 2014457-day reviewClass II21 CFR 882.5890

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Iq Technologies, Inc. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

Cleared on Aug 6, 2014 as substantially equivalent to K102598 (Hi-Dow International, Inc., 2011) and 1 other predicate after a 457-day review. Its family tree reaches back 5 generations to 1994. 8 later devices descend from it.

Decided
Aug 6, 2014
Review
457 days
Class
Class II
Product code
NUH
Recalls
None
Predicates
2

Its longest line of descent runs back 5 generations to K940301 (1994). 7 ancestors in all. 8 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2005: 1 other ancestor2017: 2 descendants cleared2020: 2 descendants cleared2014: 1 descendant cleared2019: 1 descendant cleared2021: 1 descendant cleared2023: 1 descendant clearedReference device: K090198 · Jiajian Self-Adhesive Electrode · Wuxi Jiajian Medical Instrument Co., Ltd. · 2009K940301 · Compex 2 · Biodex Medical Systems, Inc. · 1994K011880 · Compex Sport · Compex S.A. · 2002K060846 · Therapeutic Massage Companion · Endurance Therapeutics · 2007K102598 · HI-Dow-XP · Hi-Dow International, Inc. · 2011K121757 · Healthmateforever · Healthmate International, LLC · 20121990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant K121757 · Healthmateforever · Healthmate International, LLC · 2012K102598 · HI-Dow-XP · Hi-Dow International, Inc. · 2011K060846 · Therapeutic Massage Companion · Endurance Therapeutics · 2007K011880 · Compex Sport · Compex S.A. · 2002K940301 · Compex 2 · Biodex Medical Systems, Inc. · 1994−50
  1. Root · 5 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
  2. 4 generations backK011880 Compex SportCompex S.A. · 2002
  3. 3 generations backK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
  4. 2 generations backK102598 HI-Dow-XPHi-Dow International, Inc. · 2011
  5. 1 generation backK121757 HealthmateforeverHealthmate International, LLC · 2012
  6. This deviceK131290 IQ TechnologiesIq Technologies, Inc. · 2014
  7. Descendant · cites it directly · 5 of its ownK141260 Electronic Pulse StimulatorShenzhen Jingkehui Electronic Co.., Ltd. · 2014
  8. Descendant · 2 generations on · 2 of its ownK200561 StimPlus Patch, StimPlus Patch, StimPlus PatchJkh Health Co., Ltd. · 2020
  9. Descendant · 3 generations on · 1 of its ownK211942 Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623…Shenzhen Osto Technology Company Limited · 2021
  10. Descendant · 4 generations on · 0 of its ownK223428 Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A…Shenzhen Leqing Medical Instrument Co., Ltd. · 2023
  11. Descendant · cites it directly · 0 of its ownK193655 MSLS6QF TENS/PMS DeviceSelf Doctor Care, LLC · 2020

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2014: 12017: 22019: 12020: 22021: 12023: 1
2014high 2 (2017) · low 0 (2015)2026

Most influential descendants

Showing 5 of 8 · See all
  • K141260Electronic Pulse StimulatorShenzhen Jingkehui Electronic Co.., Ltd. · 2014 · cites it directly5descendants
  • K200561StimPlus Patch, StimPlus Patch, StimPlus PatchJkh Health Co., Ltd. · 2020 · 2 generations on2descendants
  • K211942Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)Shenzhen Osto Technology Company Limited · 2021 · 3 generations on1descendant
  • K223428Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A…Shenzhen Leqing Medical Instrument Co., Ltd. · 2023 · 4 generations on0descendants
  • K193655MSLS6QF TENS/PMS DeviceSelf Doctor Care, LLC · 2020 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K940301Compex 2Biodex Medical Systems, Inc.1994—
−4K011880Compex SportCompex S.A.2002—
−3K060846Therapeutic Massage CompanionEndurance Therapeutics2007—
−2K102598HI-Dow-XPHi-Dow International, Inc.2011—
−1K121757HealthmateforeverHealthmate International, LLC2012—
0 (this device)K131290IQ TechnologiesIq Technologies, Inc.2014—
+1K141260Electronic Pulse StimulatorShenzhen Jingkehui Electronic Co.., Ltd.2014—
+2K200561StimPlus Patch, StimPlus Patch, StimPlus PatchJkh Health Co., Ltd.2020—
+3K211942Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)Shenzhen Osto Technology Company Limited2021—
+4K223428Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A…Shenzhen Leqing Medical Instrument Co., Ltd.2023—
+1K193655MSLS6QF TENS/PMS DeviceSelf Doctor Care, LLC2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200410
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201720
201910
202020
202110
202310
FIG. 1 — Lineage of K131290, 1994–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K190783 Health Expert Electronic Stimulator (model…score 15.8 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K102598HI-Dow-XP
Summary page 4
…NUH, NGX Regulation Number: 21 CFR 882.5890 Device Class: II Use: Over-The-Counter 4. Predicate device Predicate Device: Powered Muscle Stimulator, JQ-5C 510(k) Number: K102598 Use: Over-The-Counter Submitter: Hi-Dow International, Inc. Predicate Device: TENS&PMS 510(k) Number: K121757 Use: Over-The-Coun…
Hi-Dow International, Inc.2011—
*K121757Healthmateforever
Summary page 4
…te Device: Powered Muscle Stimulator, JQ-5C 510(k) Number: K102598 Use: Over-The-Counter Submitter: Hi-Dow International, Inc. Predicate Device: TENS&PMS 510(k) Number: K121757 Use: Over-The-Counter Submitter: Healthmate International, LLC 5. Description of Subject Device The subject device is a Transcut…
Healthmate International, LLC2012—
†K090198Jiajian Self-Adhesive ElectrodeWuxi Jiajian Medical Instrument Co., Ltd.2009—

Also cleared against K102598: 8 other devices →

What descends from it? (8)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K141260Electronic Pulse StimulatorShenzhen Jingkehui Electronic Co.., Ltd.20145
K193655MSLS6QF TENS/PMS DeviceSelf Doctor Care, LLC20200
K170659IQ TechnologiesIq Technologies, Inc.20170
K170145Digital TENS UnitShenzhen Eapply Technology Co., Ltd.20170

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 20 years and passes through 6 companies; a new generation was cleared every 3.4 years on median.
  • None of the 7 ancestors has a recall.
  • Of its descendants, K141260 (Shenzhen Jingkehui Electronic Co.., Ltd., 2014) has gone furthest, with 5 descendants of its own.
  • 8 other devices also cite its predicate K102598.

How does its category compare?

All NUH devices

NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · NUH

15in 2025

2007: 42009: 12010: 32011: 62012: 62013: 102014: 162015: 142016: 132017: 172018: 162019: 192020: 142021: 142022: 202023: 152024: 202025: 152026 (partial year): 5
2007high 20 (2022) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NUH

119in 2025

2007: 161 days median2010: 148 days median2011: 231 days median2012: 170 days median2013: 189 days median2014: 212 days median2015: 198 days median2016: 145 days median2017: 155 days median2018: 121 days median2019: 213 days median2020: 147 days median2021: 198 days median2022: 103 days median2023: 127 days median2024: 90 days median2025: 119 days median2026 (partial year): 137 days median
2007high 231 (2011) · low 90 (2024)2026

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

2013: 12014: 92015: 112016: 132017: 212018: 182019: 52020: 82021: 72022: 22023: 42024: 72025: 7
2007high 21 (2017) · low 0 (2007)2025

MAUDE reports naming product code NUH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007416100
20080—00
20091—00
2010314800
2011623100
2012617000
20131018901
20141621209
201514198011
201613145013
201717155021
201816121018
20191921305
20201414708
20211419807
20222010302
20231512704
2024209007
20251511907
202651370—

What is it indicated for?

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K131290: IQ Technologies.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131290

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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