FDA.reportPublic FDA data

Levina

Primary DI
04719872333296
Brand
Levina
Company
ZMI ELECTRONICS LTD.
Model
SAE-MPBFBL
Catalog number
SAE-MPBFBL
Device description
Self-adhesive electrode, butterfly type: D68x141mm + D53x111mm (Blue)
Published
2024-02-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220997000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220997000Wireless TENS/EMS, Bruno, AelaZmi Elecronics , Ltd.2022-09-01NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719872333296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719872333296047198723332964719872333296

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+88678150053mail@zmi-electronics.com

Regulatory Flags#

DUNS number
657406062
Device count
1
Lot or batch
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
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
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
06978452680085AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06978452680092AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06978452680108NURSALShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06971712722075MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-06-02
06971712726943MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-30
06971712722990SalityHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-28
03770018808086actiTENSSUBLIMEDNUH2026-05-27
03770018808093actiTENSSUBLIMEDNUH2026-05-27
03770018808109actiTENSSUBLIMEDNUH2026-05-27
03770018808116actiTENSSUBLIMEDNUH2026-05-27
03770018808253actiTENS MiniSUBLIMEDNUH2026-05-27
03770018808260actiTENS MiniSUBLIMEDNUH2026-05-27
00850080988411AUVONUAN HEALTHCARE LIMITEDNUH2026-05-06
00194346404155EquateWAL-MART STORES, INC.NUH2026-05-01
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00850044118762iHealthiHealth Labs Inc.NUH2026-04-16
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00810113683782ManaRecovery Stimulation System Manamed, Inc.NUH2025-10-03
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00850073128169AVCOOADP HEALTH LIMITEDNUH2025-09-18
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NUH2025-09-11