Where does the data come from?

U.S. FDA openFDA (510(k) clearances and device enforcement reports). Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261574

Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143) (K261574): 510(k) cleared for Hong Qiangxing (Shenzhen) Electronics Limited

Q: How to monitor Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143) (K261574): 510(k) cleared for Hong Qiangxing (Shenzhen) Electronics Limited and peer neurology records

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Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143) (K261574): 510(k) cleared for Hong Qiangxing (Shenzhen) Electronics Limited: 510(k) cleared for Hong Qiangxing (Shenzhen) Electronics Limited. Its amount of 157 is above the median of 138 (59th percentile). Dated 20 days ago, it is in the active follow-up window. Score 48/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).

Data as of 2026-11-04 · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

amount: 157 · 59th percentile of 414 FDAPulse records · 1.1x the median

Free preview: all 14 published fields of this record are shown below. Locked: 75 related CN FDAPulse records and the 5-column CSV export.

Field	Value
Record	510(k) clearance
510(k) number	K261574
Device	Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143)
Applicant	Hong Qiangxing (Shenzhen) Electronics Limited
Specialty / panel	Neurology
Product code	NUH
Device class	2
Clearance type	Traditional
Decision	Substantially Equivalent
Received	2026-05-12
Decision date	2026-10-16
Review time (days)	157
Third-party review	No
Applicant location	Shenzhen, CN
amount percentile	59th of 414 (median 138, 1.1x median)
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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-10-16
Data refreshed: 2026-11-04
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT

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Peer benchmark and outreach value: Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143) (K261574): 510(k) cleared for Hong Qiangxing (Shenzhen) Electronics Limited and 76 CN peers

Your role Typical deal size (USD) Assumed reply-to-deal rate (%)

CN FDAPulse records like this one: 76
Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143) (K261574): 510(k) cleared for Hong Qiangxing (Shenzhen) Electronics Limited's amount: 59th percentile of 414 records
Timing: Medium: dated in the last 30 days
Estimated pipeline if you contact every CN peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

48 / 100 Predicate Speed & CAPA Advisory Opportunity Score

157-day review, longer than typical.
Posted 20 days ago.

What is the FDAPulse record for Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143) (K261574): 510(k) cleared for Hong Qiangxing (Shenzhen) Electronics Limited?

Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143) (K261574) by Hong Qiangxing (Shenzhen) Electronics Limited was cleared on 2026-10-16 after 157 days of review.

How does Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143) (K261574): 510(k) cleared for Hong Qiangxing (Shenzhen) Electronics Limited compare to other FDAPulse records?

Its amount of 157 sits in the upper half (59th percentile) of 414 records; the median is 138. It is 20 days old, still within a typical 45-day follow-up window.

Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143) (K261574) vs. top 3 peers

Organization	Location	Record date
Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143) (K261574)	CN	2026-10-16
7D Surgical System (10-0001) (K260403)	CA	2026-10-19
cCeLL - In vivo (K260315)	KR	2026-10-16
Neurora (K260064)	NH	2026-10-02

How to monitor Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143) (K261574): 510(k) cleared for Hong Qiangxing (Shenzhen) Electronics Limited and peer neurology records

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