FDA 510(k)

Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2

Numéro K : K221384 · 2022-06-11

Date de décision2022-06-11

Code produitNUH

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 is the device name listed in this FDA 510(k) record. The listed applicant is Hivox Biotek, Inc.. It received FDA 510(k) clearance on 2022-06-11 under 510(k) number K221384. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2?

Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 is a medical device that received FDA 510(k) clearance on 2022-06-11. The listed applicant is Hivox Biotek, Inc.. The 510(k) number is K221384.

When did Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 receive FDA 510(k) clearance?

Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 received FDA 510(k) clearance on 2022-06-11, under 510(k) number K221384.

Who is the listed applicant for Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2?

The FDA 510(k) record lists Hivox Biotek, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2?

The FDA product code for Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 is NUH.

Essais cliniques associés

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Autres dossiers indiquant Hivox Biotek, Inc. en tant que demandeur

K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)K242815POCKET TENS (EP-300)K232675Heating Tens, FT-615 K223308HEATING TENS/EMS, FT-810R K211403HIVOX OTC Electrical Stimulator, FT610-B K203574HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2

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Dispositifs connexes (Code : 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

Source officielle

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