Belifu

FDA UDI

Class II (US FDA UDI)

by Hong Qiangxing (Shenzhen) Electronics Limited

Identity

Trade Name: Belifu FDA UDI
Generic Name: Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Model / Reference: SM9126 FDA UDI

Identifiers

Primary DI / UDI-DI: 06971712723997 FDA UDI
510(k) Number: K121719 FDA UDI
FDA Product Code: GZJ FDA UDI
GMDN Term: Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5890 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Physical therapy transcutaneous neuromuscular electrical stimulation system

Belifu is a highly advanced transcutaneous neuromuscular electrical stimulation system designed to provide effective and safe treatment for various neuromuscular symptoms and disorders. As a physical therapy transcutaneous neuromuscular electrical stimulation device, Belifu offers a range of clinical applications including relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation. With its advanced technology and user-friendly design, Belifu is ideal for healthcare professionals seeking to provide comprehensive treatment options.

COMPEX — DJO, LLC · Class II
RS-4s Muscle Stimulator System (R) — Rs Medical · Class II
BodyMed — BOXOUT, LLC · Class II
veicomtech — Guangzhou Huakai Electronic Technology Co., Ltd. · Class II
Therapist’s Choice® TENS2N1 Combo — CLINICAL HEALTH SERVICES, INC. · Class II
iSelfCare — HEALTHMATE INTERNATIONAL, LLC · Class II
JMOON — Shenzhen Ulike Smart Electronics Co., Ltd. · Class II
INNOVO — Atlantic Therapeutics, Ltd. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Hong Qiangxing (Shenzhen) Electronics Limited

Sources (1)

FDA UDI edce9f66-b1bc-4bf1-aafe-60afed9925f1 33 fields · synced Jul 26, 2026

Belifu

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)