FDA.reportPublic FDA data

Aculife

Primary DI
04719874910013
Brand
Aculife
Company
INNO HEALTH TECHNOLOGY CO., LTD.
Model
IDOC-01
Published
2024-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
BWKStimulator, Electro-Acupuncture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWKStimulator, Electro-AcupunctureUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719874910013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719874910013047198749100134719874910013

GMDN Terms#

Term, Definition table
TermDefinition
Acupuncture electrical stimulation systemAn electrically-powered unit designed to be used specifically to apply electrical stimuli to acupuncture sites (electroacupuncture). It is an external low-intensity, low frequency pulse (usually 1 to 100 pulses per second), multimode generator intended to connect to acupuncture electrodes. The electrodes may be placed either on the skin, or through acupuncture needles that penetrate the skin at the acupuncture points. Some may use a probe to detect the acupuncture sites using visual or audio signals.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658605845
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
74719874910005AculifeIDOC-01 Vitall2018-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00768627017145Blue Diamond 360 Needle StimulatorNORTH COAST MEDICAL, INC.BWK2026-06-01
00768627017152Blue Diamond 360 Needle Stimulator Lead Wires - Alligator ClipNORTH COAST MEDICAL, INC.BWK2026-06-01
00768627017169Blue Diamond 360 Needle Stimulator Lead Wires - PigtailNORTH COAST MEDICAL, INC.BWK2026-06-01
06973774194265QIJIUBozhou Rongjian Medical Appliance Co., Ltd.BWK2026-04-03
08908006064281ANSiSTIM-PP NEUROSTIMULATION MEDTECH PRIVATE LIMITEDBWK2026-03-16
06932307410395JIAJIANWuxi Jiajian Medical Instrument Co.,Ltd.BWK2026-03-04
06932307410401JIAJIANWuxi Jiajian Medical Instrument Co.,Ltd.BWK2026-03-04
06932307410449JIAJIANWuxi Jiajian Medical Instrument Co.,Ltd.BWK2026-03-04
06932307410456JIAJIANWuxi Jiajian Medical Instrument Co.,Ltd.BWK2026-03-04
06972011718424JIAJIANWuxi Jiajian Medical Instrument Co.,Ltd.BWK2026-03-03
06972011718431JIAJIANWuxi Jiajian Medical Instrument Co.,Ltd.BWK2026-03-03
14897076722812SEARCH+STIM PROBE AXUS ES-5TENS PLUS INDUSTRIAL COMPANYBWK2022-11-14
14897076720092AXUS ES-5TENS PLUS INDUSTRIAL COMPANYBWK2021-03-30
B960NSS201NSS NeuroStimNeuraxis, Inc.BWK2020-11-09
B327NSS201NSS NeurostimKEY ELECTRONICS, INC.BWK2019-03-22
B327NSS202NSS MFSKEY ELECTRONICS, INC.BWK2019-03-22
74719874910005AculifeINNO HEALTH TECHNOLOGY CO., LTD.BWK2018-11-27
00810011252509JiajianWuxi Jiajian Medical Instrument Co.,Ltd.BWK2018-11-26
08150050225006JiajianWuxi Jiajian Medical Instrument Co.,Ltd.BWK2016-10-21
10815005022400JiajianWuxi Jiajian Medical Instrument Co.,Ltd.BWK2016-10-21
04983087008403ES-130ITO CO., LTD.BWK2016-09-24
00831592004196Yingdi Multi Purpose Health DeviceUPC MEDICAL SUPPLIES, INC.BWK2016-09-23
00831592004202Yingdi Multi Purpose Health DeviceUPC MEDICAL SUPPLIES, INC.BWK2016-09-23
00831592004219Yingdi Multi Purpose Health DeviceUPC MEDICAL SUPPLIES, INC.BWK2016-09-23