FDA 510(k)

Transcutaneous Electrical Nerve Stimulator Model: ST-304

N.º K: K221092 · 2022-09-13

SolicitanteShenzhen Future Electronic Co., Ltd.

Fecha de decisión2022-09-13

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Transcutaneous Electrical Nerve Stimulator Model: ST-304 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Future Electronic Co., Ltd.. It received FDA 510(k) clearance on 2022-09-13 under 510(k) number K221092. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Transcutaneous Electrical Nerve Stimulator Model: ST-304?

Transcutaneous Electrical Nerve Stimulator Model: ST-304 is a medical device that received FDA 510(k) clearance on 2022-09-13. The listed applicant is Shenzhen Future Electronic Co., Ltd.. The 510(k) number is K221092.

When did Transcutaneous Electrical Nerve Stimulator Model: ST-304 receive FDA 510(k) clearance?

Transcutaneous Electrical Nerve Stimulator Model: ST-304 received FDA 510(k) clearance on 2022-09-13, under 510(k) number K221092.

Who is the listed applicant for Transcutaneous Electrical Nerve Stimulator Model: ST-304?

The FDA 510(k) record lists Shenzhen Future Electronic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Transcutaneous Electrical Nerve Stimulator Model: ST-304?

The FDA product code for Transcutaneous Electrical Nerve Stimulator Model: ST-304 is NUH.

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Otros registros que enlistan a Shenzhen Future Electronic Co., Ltd. como solicitante

K251662Dispositivo de Terapia de Compresión de Aire (ST-504); Dispositivo de Terapia de Compresión de Aire (ST-505); Dispositivo de Terapia de Compresión de Aire (ST-506); Dispositivo de Terapia de Compresión de Aire (ST-507)K213745Dispositivo de Terapia de Compresión de Aire, modelo: ST-502

Dispositivos relacionados (Código: NUH)

K261131Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.)Shenzhen Osto Medical Technology Co.,Ltd K260412TENS 7000 Rechargeable 4 Channel (TENS 7000H)Shenzhen Dongdixin Technology Co., Ltd.K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)Hivox Biotek, Inc.K253896TENS/EMS device (GUSE01)Globalcare Medical Technology Co., Ltd.K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)Hong Qiangxing (Shenzhen) Electronics Limited

Fuente oficial

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