FDA 510(k)

ThermaCare Quick Therapy TENS

Numéro K : K181102 · 2018-09-15

Date de décision2018-09-15

Code produitNUH

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

ThermaCare Quick Therapy TENS is the device name listed in this FDA 510(k) record. The listed applicant is Pfizer, Inc.. It received FDA 510(k) clearance on 2018-09-15 under 510(k) number K181102. 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 ThermaCare Quick Therapy TENS?

ThermaCare Quick Therapy TENS is a medical device that received FDA 510(k) clearance on 2018-09-15. The listed applicant is Pfizer, Inc.. The 510(k) number is K181102.

When did ThermaCare Quick Therapy TENS receive FDA 510(k) clearance?

ThermaCare Quick Therapy TENS received FDA 510(k) clearance on 2018-09-15, under 510(k) number K181102.

Who is the listed applicant for ThermaCare Quick Therapy TENS?

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

What is the FDA product code for ThermaCare Quick Therapy TENS?

The FDA product code for ThermaCare Quick Therapy TENS is NUH.

Essais cliniques associés

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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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