HIVOX BIOTEK INC.

Unified Business No.

70847515

Industry

Other Manufacturing (2,432)

Main products

Medical devices & supplies (878)

Location

5F., No. 123, Xingde Rd., Sanchong Dist., New Taipei City 241458, Taiwan (R.O.C.)↗
New Taipei City (16,829) · Sanchong Dist. (1,863)

Listing

Not publicly issued (84,625)

Organisation type

Company Limited by Shares

Representative

Tuan Wei

Phone

02-85112668

Website

https://www.hivox-biotek.com/

Exporter

Yes — registered with the Trade Administration

Annual revenue band

< NT$20M estimated

Ownership

Foreign-owned · Cayman Islands · ChinaConsumerFund,L.P (Cayman)

North American market

FDA 510(k) clearance FDA medical device registration Health Canada medical device licence

Representative tenure

In office since at least 2015 (11+ years)

Certifications 8

• Medical device license (188)Official registry Valid until 2010-04-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2020-10-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2020-10-18 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2020-10-18 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-12-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2021-07-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2026-08-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2017-02-03 · Taiwan Food and Drug Administration (TFDA)

Processes & materials 2

• Quenching & annealing (147) · Surface treatmentSelf-reported
• Electroplating (567) · Surface treatmentSelf-reported

Patents 13

• 2025 Supporting combination structure of vibration massager strap
• 2025 Flexible stable support structure of vibration massager
• 2025 Shockproof head structure of foot therapy massager

North American market evidence 20

• FDA 510(k) clearance K260425 2026-06-16
  TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)
• FDA 510(k) clearance K242815 2024-12-17
  POCKET TENS (EP-300)
• FDA 510(k) clearance K232675 2023-10-05
  Heating Tens, FT-615
• FDA 510(k) clearance K223308 2023-05-13
  HEATING TENS/EMS, FT-810R
• FDA 510(k) clearance K221384 2022-06-11
  Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2
• FDA 510(k) clearance K211403 2021-10-15
  HIVOX OTC Electrical Stimulator, FT610-B
• FDA 510(k) clearance K203574 2021-03-10
  HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2
• FDA 510(k) clearance K192264 2019-11-08
  HIVOX Spopad EMS SP-911, SP-921
• FDA 510(k) clearance K190347 2019-03-15
  HIVOX OTC Electrical Stimulator
• FDA 510(k) clearance K171803 2017-11-29
  HIVOX OTC Electrical Stimulator
• FDA 510(k) clearance K143737 2015-07-27
  EM25 - glute toning device
• FDA 510(k) clearance K141921 2015-01-16
  HIVOX SPOPAD EMS
• FDA 510(k) clearance K131720 2014-07-25
  HIVOX SELF ADHESIVE ELECTRODE GEL PADS
• FDA 510(k) clearance K140650 2014-06-27
  HIVOX ELECTRIC STIMULATOR OTC TENS
• FDA 510(k) clearance K112392 2012-03-19
  HIVOX BIOTEK INC.
• FDA 510(k) clearance K092448 2010-03-30
  HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2
• FDA 510(k) clearance K021952 2003-05-02
  HIVOX DREAMATE DM-800
• FDA 510(k) clearance K020471 2002-05-02
  HIVOX EAR THERMOMETER, TS SERIES
• FDA medical device registration 9611558 2002-08-21 – 2025-01-28
  Stimulator, Nerve, Transcutaneous, Over-The-Counter; Stimulator, Muscle, Powered, For Muscle Conditioning; Electrode, Cutaneous and more (6)
• Health Canada medical device licence 116460

Recent changes 1

• 2026-08-21
  Certification expiryMedical device license (Class II) certificate expired on 2026-08-21

RSS feed · Recent changes at Taiwanese manufacturers →

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