Heating Tens/Ems, FT-810R

FDA 510(k) K223308 · Hivox Biotek, Inc.

Substantially Equivalent

510(k) numberK223308

Submission

Device name
Heating Tens/Ems, FT-810R
Applicant
Hivox Biotek, Inc.
New Taipei City, TW
Received
October 28, 2022
Decision date
May 13, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5890
Specialty
Neurology

TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES

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More from Sigma Biomedical

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K232675Heating Tens, FT-615NUH · Special 10/05/2023SE
K221384Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2NUH · Special 06/11/2022SE
K211403HIVOX OTC Electrical Stimulator, FT610-BNUH · Traditional 10/15/2021SE
K203574HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2NUH · Traditional 03/10/2021SE
K192264HIVOX Spopad EMS SP-911, SP-921NGX · Special 11/08/2019SE
K190347HIVOX OTC Electrical StimulatorNUH · Special 03/15/2019SE
K171803HIVOX OTC Electrical StimulatorNUH · Traditional 11/29/2017SE
K143737EM25 - glute toning deviceNGX · Traditional 07/27/2015SE

Questions and answers

When was Heating Tens/Ems, FT-810R cleared by the FDA?

Heating Tens/Ems, FT-810R (K223308) received a 510(k) decision of Substantially Equivalent on May 13, 2023, 197 days after the submission was received.

What is the product code of K223308?

The FDA product code is NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter, a Class II (moderate risk) device regulated under 21 CFR 882.5890.