FDA.reportPublic FDA data

HTG Life

Primary DI
00851256007073
Brand
HTG Life
Company
FRAMEWERK LLC
Model
PL-029G
Device description
Analgesic TENS system
Published
2017-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851256007070PackageGS11In Commercial Distribution
20851256007077PackageGS120In Commercial Distribution
00851256007073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085125600707010851256007070
2085125600707720851256007077
00851256007073008512560070738512560070730851256007073

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic transcutaneous electrical nerve stimulation systemAn assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080774091
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971712727704YUN MANSIONHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-26
00850080988466AUVONUAN HEALTHCARE LIMITEDNUH2026-05-24
06932307410418JIAJIANWuxi Jiajian Medical Instrument Co.,Ltd.NUH2026-03-04
00714905710024Fab StimCOMPASS HEALTH BRANDS CORP.NUH2026-02-06
06971292004301AUVONShenzhen Yuwen E-Commerce Co., Ltd.NUH2026-01-21
00850016867407Pixie CupPixie Cup LLCNUH2026-01-09
06971292004295AUVONShenzhen Yuwen E-Commerce Co., Ltd.NUH2025-12-17
00810093080786PainPod Hi-Dow International IncorporatedNUH2025-12-09
00810093080793PainPod Hi-Dow International IncorporatedNUH2025-12-09
04719871185605iSTIMEVERYWAY MEDICAL INSTRUMENTS CO., LTD.NUH2025-12-03
04719871186039EverywayEVERYWAY MEDICAL INSTRUMENTS CO., LTD.NUH2025-12-03
16978452680020EPULSEShenzhen Jiantuo Electronics Co., LtdNUH2025-12-01
16978452680037KONGZEEShenzhen Jiantuo Electronics Co., LtdNUH2025-12-01
06971292004127AUVONShenzhen Yuwen E-Commerce Co., Ltd.NUH2025-09-22
10850073128180AVCOOADP HEALTH LIMITEDNUH2025-09-19
10850073128197AVCOOADP HEALTH LIMITEDNUH2025-09-19
16971292004117AUVONShenzhen Yuwen E-Commerce Co., Ltd.NUH2025-09-19
10850073128166AVCOOADP HEALTH LIMITEDNUH2025-09-18
06971292004103AUVONShenzhen Yuwen E-Commerce Co., Ltd.NUH2025-09-11
16971292008078AUVONShenzhen Yuwen E-Commerce Co., Ltd.NUH2025-09-02
16970890320681AUVONShenzhen As-Tec Technology Co.,Ltd.NUH2025-08-30
00850073128121AVCOOADP HEALTH LIMITEDNUH2025-08-25
10850073128135AVCOOADP HEALTH LIMITEDNUH2025-08-25
06973602730719reajoyTOP-RANK HEALTH CARE CO., LTD.NUH2025-08-21
16978452680013NURSALShenzhen Jiantuo Electronics Co., LtdNUH2025-08-21
06971292008064AUVONShenzhen Yuwen E-Commerce Co., Ltd.NUH2025-08-12
16971712724717UnimedHong Qiangxing (Shen Zhen) Electronics LimitedNUH2025-08-11
00851221006803Quell 2.0NEUROMETRIX, INC.NUH2025-08-01
16978146200107SinrelSHENZHEN SINREL TECH LTDNUH2025-07-14
04251784906101HealyHealy GmbHNUH2025-07-10