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FDA 510(k)

HEATING TENS/EMS, FT-810R

K-Number: K223308 · 2023-05-13

ApplicantHivox Biotek, Inc.
Decision Date2023-05-13
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HEATING TENS/EMS, FT-810R 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 2023-05-13 under 510(k) number K223308. 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 HEATING TENS/EMS, FT-810R?

HEATING TENS/EMS, FT-810R is a medical device that received FDA 510(k) clearance on 2023-05-13. The listed applicant is Hivox Biotek, Inc.. The 510(k) number is K223308.

When did HEATING TENS/EMS, FT-810R receive FDA 510(k) clearance?

HEATING TENS/EMS, FT-810R received FDA 510(k) clearance on 2023-05-13, under 510(k) number K223308.

Who is the listed applicant for HEATING TENS/EMS, FT-810R?

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, FT-810R?

The FDA product code for HEATING TENS/EMS, FT-810R 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-615K221384Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2K211403HIVOX OTC Electrical Stimulator, FT610-BK203574HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2

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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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