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FDA 510(k)

HIVOX OTC Electrical Stimulator

K-Number: K190347 · 2019-03-15

ApplicantHivox Biotek, Inc.
Decision Date2019-03-15
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HIVOX OTC Electrical Stimulator 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 2019-03-15 under 510(k) number K190347. 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 HIVOX OTC Electrical Stimulator?

HIVOX OTC Electrical Stimulator is a medical device that received FDA 510(k) clearance on 2019-03-15. The listed applicant is Hivox Biotek, Inc.. The 510(k) number is K190347.

When did HIVOX OTC Electrical Stimulator receive FDA 510(k) clearance?

HIVOX OTC Electrical Stimulator received FDA 510(k) clearance on 2019-03-15, under 510(k) number K190347.

Who is the listed applicant for HIVOX OTC Electrical Stimulator?

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 HIVOX OTC Electrical Stimulator?

The FDA product code for HIVOX OTC Electrical Stimulator is NUH.

Other records listing Hivox Biotek, 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.

K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)K242815POCKET TENS (EP-300)K232675Heating Tens, FT-615K223308HEATING TENS/EMS, FT-810RK221384Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2K211403HIVOX OTC Electrical Stimulator, FT610-B

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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

View on FDA Database →

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

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