510(k) · Cleared

Cleared

Pain Therapy System, Model PTS-II

K150277510(k) TraditionalCleared Feb 12, 2016372-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

Counter Scientific Development (Gz), Ltd. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

Cleared on Feb 12, 2016 as substantially equivalent to K124055 (Endurance Therapeutics, 2013) after a 372-day review. Its family tree reaches back 1 generation to 2013. 3 later devices descend from it.

Decided: Feb 12, 2016
Review: 372 days
Class: Class II
Product code: NUH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K124055 (2013). 3 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK124055 T1040 Aka AurawaveEndurance Therapeutics · 2013
This deviceK150277 Pain Therapy System, Model PTS-IICounter Scientific Development (Gz), Ltd. · 2016
Descendant · cites it directly · 2 of its ownK163611 Pain Therapy DeviceGuangzhou Xinbo Electronic Co., Ltd. · 2017
Descendant · 2 generations on · 0 of its ownK230443 TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)Jiangxi Royall Smart Technology Co., Ltd. · 2023
Descendant · 2 generations on · 0 of its ownK200237 Transcutaneous Electronic Nerve StimulatorShenzhen Kentro Medical Electronics Co., Ltd. · 2020

Most influential descendants

Showing 3 of 3 · See all

K163611Pain Therapy DeviceGuangzhou Xinbo Electronic Co., Ltd. · 2017 · cites it directly2descendants
K230443TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)Jiangxi Royall Smart Technology Co., Ltd. · 2023 · 2 generations on0descendants
K200237Transcutaneous Electronic Nerve StimulatorShenzhen Kentro Medical Electronics Co., Ltd. · 2020 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K124055	T1040 Aka Aurawave	Endurance Therapeutics	2013	—
0 (this device)	K150277	Pain Therapy System, Model PTS-II	Counter Scientific Development (Gz), Ltd.	2016	—
+1	K163611	Pain Therapy Device	Guangzhou Xinbo Electronic Co., Ltd.	2017	—
+2	K230443	TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)	Jiangxi Royall Smart Technology Co., Ltd.	2023	—
+2	K200237	Transcutaneous Electronic Nerve Stimulator	Shenzhen Kentro Medical Electronics Co., Ltd.	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	0
2020	1	0
2023	1	0

FIG. 1 — Lineage of K150277, 2013–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (1)

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	Applicant	Decided	Recalls
*	K124055	T1040 Aka Aurawave Summary page 4 …ode: NUH, NGX, NYN, GZJ Device Class: II 3. Predicate (cleared) Device: OTC TENS, Model T1040 aka Aurawave 510(k) Number: K124055 Manufacturer: Endurance Therapeutics 4. Description of Proposed Device: The Pain Therapy…	Endurance Therapeutics	2013	—
†	K132588	Adhesive Electrodes	Top-Rank Health Care Equipment Co., Ltd.	2013	—

Also cleared against K124055: 1 other device →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K163611	Pain Therapy Device	Guangzhou Xinbo Electronic Co., Ltd.	2017	2

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?

Its one ancestor has no recall.
Of its descendants, K163611 (Guangzhou Xinbo Electronic Co., Ltd., 2017) has gone furthest, with 2 descendants of its own.
1 other device also cites its predicate K124055.

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. 2016, this device’s year, is highlighted.

FDA decisions per year · NUH

15in 2025

2007high 20 (2022) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NUH

119in 2025

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

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

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	4	161	0
2008	0	—	0
2009	1	—	0
2010	3	148	0
2011	6	231	0
2012	6	170	0
2013	10	189	1
2014	16	212	9
2015	14	198	11
2016	13	145	13
2017	17	155	21
2018	16	121	18
2019	19	213	5
2020	14	147	8
2021	14	198	7
2022	20	103	2
2023	15	127	4
2024	20	90	7
2025	15	119	7
2026	5	137	—

What is it indicated for?

To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back due to strain from exercise or normal household work activities (Choose Mode A, B, or C) To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (Arms) due to strain from exercise or normal household work activities (Choose Mode A, B or C) To be used for temporary relief of pain associated with sore…

Read the full statement (143 words)

To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back due to strain from exercise or normal household work activities (Choose Mode A, B, or C)

To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (Arms) due to strain from exercise or normal household work activities (Choose Mode A, B or C)

To be used for temporary relief of pain associated with sore and aching muscles in the lower extremities (Legs) due to strain from exercise or normal household work activities (Choose Mode A, B or C)

To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with Arthritis (Choose Mode A)

To stimulate healthy muscles in order to improve and facilitate muscle performance (Choose Mode B)

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K150277 · printed Nov 6, 2026

Cite this page

510(k) Report. “K150277: Pain Therapy System, Model PTS-II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150277

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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