FDA 510(k) clearance · back to tracker

Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143)

Hong Qiangxing (Shenzhen) Electronics Limited cleared K261574 on 2026-10-16, decision: substantially equivalent

K-number

K261574

Sponsor

Hong Qiangxing (Shenzhen) Electronics Limited

Device

Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143)

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-10-16

Product code

NUH

Advisory committee

Neurology

Medical specialty

Neurology

Regulation number

882.5890

Official FDA record

Open K261574on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.