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FDA 510(k)

ThermaCare Quick Therapy TENS

K-Number: K181102 · 2018-09-15

ApplicantPfizer, Inc.
Decision Date2018-09-15
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07542886A Study to Learn How Different Injector Pens Affect the Study Medicine Called Genotropin (Somatropin) Delivery and Taken up Into the Blood in Healthy AdultsCOMPLETED

Other records listing Pfizer, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA N18286Agent, absorbable hemostatic, collagen based

Related Devices (Code: NUH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 LimitedK251958VEINOPLUS BackDynapulse Medical

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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