FDA.reportPublic FDA data

PowerDot

Primary DI
04719872330394
Brand
PowerDot
Company
ZMI ELECTRONICS LTD.
Model
PD-01MR
Catalog number
PD-01M
Device description
PowerDot PD-01M Muscle Stimulator, Red (with PowerDot Mobile Application)
Published
2018-02-12
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGXStimulator, Muscle, Powered, For Muscle ConditioningPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719872330417PackageGS11In Commercial Distribution
14719872330414PackageGS12In Commercial Distribution
04719872330394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719872330417047198723304174719872330417
1471987233041414719872330414
04719872330394047198723303944719872330394

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy ultrasound/neuromuscular stimulation systemAn assembly of devices that includes a neuromuscular electrical stimulator as an integral part of a therapeutic ultrasound system intended for the simultaneous delivery of ultrasound and electrical energies for physical therapy, typically to help prevent scar tissue formation in healing tissues and to help reduce muscle spasms and pain; it may in addition be capable of delivering either energy alone. The system is designed to produce a rhythmic contraction/release of injured muscles to promote the removal of metabolic by-products while applying ultrasound treatments.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
657406062
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719872330592PowerDotPD-01MTPD-01MT2019-12-10
04719872330318PowerDotPD-01BPD-012016-09-23
04719872330325PowerDotPD-01RPD-012016-09-23
04719872330332PowerDotPD-01WPD-012016-09-23
04719872330387PowerDotPD-01MBPD-01M2018-02-12
04719872333104LevinaPFR-01-NSPFR-01-NS2026-04-14
04719872333593LevinaPFR-02-NSPFR-02-NS2026-04-14
04719872333616LevinaPFR-03-NSPFR-03-NS2026-04-14
04719872334033LevinaRS-48RS-482026-04-14
04719872332039Levina RS-18RS-182024-02-19
04719872332022Levina RS-18RS-182024-02-19
04719872332107LevinaRS-38RS-382024-02-19
04719872333296LevinaSAE-MPBFBLSAE-MPBFBL2024-02-19
04719872333302LevinaSAE-MPBFPKSAE-MPBFPK2024-02-19
04719872333319LevinaSAE-MPBFPK1SAE-MPBFPK12024-02-19
04719872333357LevinaSAE-MPBFBL1SAE-MPBFBL12024-02-19
04719872333371LevinaSAE-MPBFBL2SAE-MPBFBL22024-02-19
04719872333395LevinaSAE-MPBFPK2SAE-MPBFPK22024-02-19
04719872330035MettlerME4000MTD40002016-09-23
04719872332503NeuroMDRS-18RS-18-MD2023-06-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971712725908MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-25
00850080988657AUVONUAN HEALTHCARE LIMITEDNGX2026-07-22
06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-09
06971712722693DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-09
00850080988572AUVONUAN HEALTHCARE LIMITEDNGX2026-07-03
06971712727636ONENTECHHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-03
06978452680122AUVONShenzhen Jiantuo Electronics Co., LtdNGX2026-07-01
00850085485021AUVONAnsion Technology (GuangDong) Co. Ltd.NGX2026-06-26
00850085485038AUVONAnsion Technology (GuangDong) Co. Ltd.NGX2026-06-26
00850085485045AUVONAnsion Technology (GuangDong) Co. Ltd.NGX2026-06-26
00850085485007AVCOOAnsion Technology (GuangDong) Co. Ltd.NGX2026-06-25
00850080988473AUVONUAN HEALTHCARE LIMITEDNGX2026-06-24
06978452680085AUVONShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
06978452680092AUVONShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
06978452680108NURSALShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
06971712722075MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-06-02
06971712726943MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-05-30
06971712722990SalityHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-05-28
03770018808086actiTENSSUBLIMEDNGX2026-05-27
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03770018808260actiTENS MiniSUBLIMEDNGX2026-05-27
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