FDA.reportPublic FDA data

Pure Enrichment

Primary DI
04719880810192
Brand
Pure Enrichment
Company
HIVOX BIOTEK INC.
Model
FT-240
Published
2022-06-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
IRTPad, Heating, Powered
NGXStimulator, Muscle, Powered, For Muscle Conditioning
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRTPad, Heating, PoweredPhysical Medicine2
NGXStimulator, Muscle, Powered, For Muscle ConditioningPhysical Medicine2
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221384000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221384000Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2Hivox Biotek, Inc.2022-06-11NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719880810192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719880810192047198808101924719880810192

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658030473
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719880810123TENS MAKERWE-2012022-03-22
04719880810154TENS MAKERWT-110-22022-02-11
04719880810000TENS MAKERWT-1102021-05-26
04719880810147TENS MAKERWT-110-RF42022-02-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06971763600889ROOVJOYShenzhen roundwhale technology co. LTD.NUH2026-11-05
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00622356776936Shark FacialPro GlowSharkNinja Operating LLCIRT2026-10-27
00622356729444Shark™ DePuffi™SharkNinja Operating LLCIRT2026-10-26
00810050289252HYPERICENORMATEC INDUSTRIES LPIRT2026-10-19
00810050289269HYPERICENORMATEC INDUSTRIES LPIRT2026-10-19
00810050289276HYPERICENORMATEC INDUSTRIES LPIRT2026-10-19
00810050289283HYPERICENORMATEC INDUSTRIES LPIRT2026-10-19
00810050289290HYPERICENORMATEC INDUSTRIES LPIRT2026-10-19
00810050289306HYPERICENORMATEC INDUSTRIES LPIRT2026-10-19
00810093080854PainPodHi-Dow International IncorporatedNUH2026-10-19
00810093080854PainPodHi-Dow International IncorporatedNGX2026-10-19
06971712720415CriterionHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-10-15
06971712725922DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-10-13
06971712725922DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-10-13
00850080988671AUVONUAN HEALTHCARE LIMITEDNGX2026-10-08
00850080988671AUVONUAN HEALTHCARE LIMITEDNUH2026-10-08
00850080988688AUVONUAN HEALTHCARE LIMITEDNUH2026-10-08
00850080988688AUVONUAN HEALTHCARE LIMITEDNGX2026-10-08
00850080988695AUVONUAN HEALTHCARE LIMITEDNGX2026-10-08
00850080988695AUVONUAN HEALTHCARE LIMITEDNUH2026-10-08
00850092200006PEPPERPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200013PepperPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200020PepperPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200037PepperPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200044PepperPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200051PepperPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200068PepperPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200075PepperPEPPER INTERACTIVE INC.NGX2026-10-05