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

**Predicate Speed & CAPA Advisory Opportunity Score:** 48/100

| 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 |

## Why this score
- 157-day review, longer than typical.
- Posted 20 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261574). Last refreshed: 2026-11-04T21:30:53.898Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.