FDA.reportPublic FDA data

PURE ENRICHMENT

Primary DI
B311PETNEMHT0
Brand
PURE ENRICHMENT
Company
BEAR DOWN CONSULTING
Model
PETNEMHT
Published
2022-08-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
B311PETNEMHT1PackageHIBCC32In Commercial Distribution
B311PETNEMHT2PackageHIBCC4In Commercial Distribution
B311PETNEMHT0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Regulatory Flags#

DUNS number
040869867
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
00853975005675Pure EnrichmentPEGELPAK2023-04-07
B311PEBRPUMP0PURE ENRICHMENTPEBRPUMP2018-12-03
00810115635185Pure EnrichmentPEHUTRB2G-W2025-09-08
B311PEPULSERT0PURE ENRICHMENTPEPULSE-RT2022-07-22
00810115633235VeriluxVT54WW62024-10-07
00768533810007VeriluxVT20WW12024-09-22
00810115633280Pure EnrichmentPEHPWD2-PE2024-08-28
B311PETNHTPR0PURE ENRICHMENTPETNHTPR2023-12-15
B311PETNHTPR1PURE ENRICHMENTPETNHTPR2023-12-15
B311PEHTNPDS20PURE ENRICHMENTPEHTNPDS22023-12-14
B311PEHTNPDS50PURE ENRICHMENTPEHTNPDS52023-12-14
B311PEHTNPDS21PURE ENRICHMENTPEHTNPDS22023-12-14
B311PEHTNPDS51PURE ENRICHMENTPEHTNPDS52023-12-14
00768533140043VeriluxVT32WW32023-05-17
00768533140050VeriluxVT31WW32023-05-17
00768533140067VeriluxVT43WW32023-05-17
00768533140098VeriluxVT42WW32023-05-17
00768533140104VeriluxVT52WW32023-05-17
00817387024228VeriluxVT37WW12023-05-17
00817387025799VeriluxVT43MB32023-05-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978452680085AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06978452680085AUVONShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
06978452680092AUVONShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
06978452680092AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06978452680108NURSALShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
06978452680108NURSALShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06971712722075MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-06-02
06971712722075MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-06-02
06971712726943MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-30
06971712726943MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-05-30
06971712722990SalityHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-28
06971712722990SalityHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-05-28
03770018808086actiTENSSUBLIMEDNGX2026-05-27
03770018808086actiTENSSUBLIMEDNUH2026-05-27
03770018808093actiTENSSUBLIMEDNUH2026-05-27
03770018808093actiTENSSUBLIMEDNGX2026-05-27
03770018808109actiTENSSUBLIMEDNUH2026-05-27
03770018808109actiTENSSUBLIMEDNGX2026-05-27
03770018808116actiTENSSUBLIMEDNUH2026-05-27
03770018808116actiTENSSUBLIMEDNGX2026-05-27
03770018808253actiTENS MiniSUBLIMEDNUH2026-05-27
03770018808253actiTENS MiniSUBLIMEDNGX2026-05-27
03770018808260actiTENS MiniSUBLIMEDNUH2026-05-27
03770018808260actiTENS MiniSUBLIMEDNGX2026-05-27
00199874125305Muscle StimulatorShenzhen Yiran Intelligence Co., Ltd.NGX2026-05-08
00194346404155EquateWAL-MART STORES, INC.NUH2026-05-01
00810060832851Venus NovaVenus Concept Inc.NGX2026-04-15
00810093080786PainPod Hi-Dow International IncorporatedNGX2025-12-09
00810093080793PainPod Hi-Dow International IncorporatedNGX2025-12-09
00810140062680RENPHOJoicom CorporationNGX2025-10-20