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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

TENS&EMS (HZ9151B, HZ9151C, HZ9151D)

Manufacturer

Hong Qiangxing (Shenzhen) Electronics Limited

Date Cleared

2025-12-23

(29 days)

Product Code

Regulation Number

Type

Panel

Age Range

All

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

TENS:
The device is used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, leg and feet, due to strain from exercise or normal household and work activities.

EMS:
The device is used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Device Description

Not Found

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