FDA.reportPublic FDA data

PowerDot

Primary DI
04719872330318
Brand
PowerDot
Company
ZMI ELECTRONICS LTD.
Model
PD-01B
Catalog number
PD-01
Device description
PowerDot PD-01 Muscle Stimulator, Black (with PowerDot Mobile Application)
Published
2016-09-23
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
04719872330356PackageGS11In Commercial Distribution
14719872330353PackageGS12In Commercial Distribution
04719872330318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719872330356047198723303564719872330356
1471987233035314719872330353
04719872330318047198723303184719872330318

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
04719872330325PowerDotPD-01RPD-012016-09-23
04719872330332PowerDotPD-01WPD-012016-09-23
04719872330387PowerDotPD-01MBPD-01M2018-02-12
04719872330394PowerDotPD-01MRPD-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

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Primary DI, Brand, Company table
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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
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03770018808109actiTENSSUBLIMEDNGX2026-05-27
03770018808116actiTENSSUBLIMEDNGX2026-05-27
03770018808253actiTENS MiniSUBLIMEDNGX2026-05-27
03770018808260actiTENS MiniSUBLIMEDNGX2026-05-27
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