510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Hivox Biotek Inc.

New Taipei City, TW

HIVOX BIOTEK INC. appears in FDA device records in New Taipei City, TW. FDA records list 18 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
18
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 18 510(k) clearances for Hivox Biotek Inc. between 2002 and 2026. The busiest year on record is 2014, with 2. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Hivox Biotek Inc., by decision year
YearClearances
20021
20031
20101
20121
20142
20152
20171
20192
20212
20221
20232
20241
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)NUHSubstantially Equivalent
K242815POCKET TENS (EP-300)NUHSubstantially Equivalent
K232675Heating Tens, FT-615NUHSubstantially Equivalent
K223308HEATING TENS/EMS, FT-810RNUHSubstantially Equivalent
K221384Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2NUHSubstantially Equivalent
K211403HIVOX OTC Electrical Stimulator, FT610-BNUHSubstantially Equivalent
K203574HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2NUHSubstantially Equivalent
K192264HIVOX Spopad EMS SP-911, SP-921NGXSubstantially Equivalent
K190347HIVOX OTC Electrical StimulatorNUHSubstantially Equivalent
K171803HIVOX OTC Electrical StimulatorNUHSubstantially Equivalent
K143737EM25 - glute toning deviceNGXSubstantially Equivalent
K141921HIVOX SPOPAD EMSNGXSubstantially Equivalent
K131720HIVOX SELF ADHESIVE ELECTRODE GEL PADSGXYSubstantially Equivalent
K140650HIVOX ELECTRIC STIMULATOR OTC TENSNUHSubstantially Equivalent
K112392HIVOX BIOTEK INC.NUHSubstantially Equivalent
K092448HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2GZJSubstantially Equivalent
K021952HIVOX DREAMATE DM-800GZJSubstantially Equivalent
K020471HIVOX EAR THERMOMETER, TS SERIESFLLSubstantially Equivalent

Registered establishments

FDA registered establishments for Hivox Biotek Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96115583003255512HIVOX BIOTEK INC.5 F., NO. 123, Xingde Road, New Taipei City 24158 TW2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain