FDA 510(k)

EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only

K-Nummer: K163166 · 2017-08-11

Entscheidungsdatum2017-08-11

ProduktcodeNUH

BeratungsausschussNE

EntscheidungSubstantially Equivalent

Produktübersicht

EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only is the device name listed in this FDA 510(k) record. The listed applicant is Easywell Biomedicals, Inc.. It received FDA 510(k) clearance on 2017-08-11 under 510(k) number K163166. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only?

EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only is a medical device that received FDA 510(k) clearance on 2017-08-11. The listed applicant is Easywell Biomedicals, Inc.. The 510(k) number is K163166.

When did EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only receive FDA 510(k) clearance?

EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only received FDA 510(k) clearance on 2017-08-11, under 510(k) number K163166.

Who is the listed applicant for EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only?

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

What is the FDA product code for EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only?

The FDA product code for EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only is NUH.

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Weitere Einträge mit Easywell Biomedicals, Inc. als Antragsteller

K162509Infrared Non-contact Thermometer, Model ACT8100

Verwandte Geräte (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

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