FDA.reportPublic FDA data

Quantum Mitohormesis (QMT)

Primary DI
08885022060018
Brand
Quantum Mitohormesis (QMT)
Company
QUANTUMTX PTE. LTD.
Model
M2101
Device description
Quantum Mitohormesis (QMT) Medical Device is intended for: 1. Stimulating healthy limb muscles to improve and facilitate muscle performance. 2. Preventing or retardation of disuse atrophy of muscles.
Published
2025-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IPFStimulator, Muscle, Powered
NGXStimulator, Muscle, Powered, For Muscle Conditioning

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240348000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240348000Quantum Mitohormesis (QMT) (M2101)Quantumtx Pte. , Ltd.2024-12-19IPF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18885022060015PackageGS11In Commercial Distribution
08885022060018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1888502206001518885022060015
08885022060018088850220600188885022060018

GMDN Terms#

Term, Definition table
TermDefinition
Muscle performance enhancement electromagnetic stimulatorAn electrically-powered device designed to apply an electromagnetic (EM) field to a limb to stimulate healthy muscles, to improve muscle performance and prevent muscle atrophy. It consists of an apparatus with an open chamber into which a patient’s limb is inserted, whereby pulsed stimulation is delivered without causing muscle contraction, stress or strain; it is not designed for deep-tissue stimulation to treat musculoskeletal disorders or body pain. It is intended for use exclusively in a professional setting.

Regulatory Flags#

DUNS number
659470592
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18885022060015Quantum Mitohormesis (QMT)M21012025-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809308380041Talent-pro Electromagnetic StimulatorREMED Co.,Ltd.IPF2026-05-13
00199874125305Muscle StimulatorShenzhen Yiran Intelligence Co., Ltd.NGX2026-05-08
07898966442551IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
07898966442698IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
00810060832851Venus NovaVenus Concept Inc.NGX2026-04-15
08032625824480GLOBUSDOMINO SRLIPF2026-02-23
00714905117649Fab StimDrive Devilbiss HealthcareIPF2026-02-06
00714905710024Fab StimDrive Devilbiss HealthcareIPF2026-02-06
00810093080786PainPod Hi-Dow International IncorporatedNGX2025-12-09
00810093080793PainPod Hi-Dow International IncorporatedNGX2025-12-09
00810140062680RENPHOJoicom CorporationNGX2025-10-20
00810140062680RENPHOJoicom CorporationIPF2025-10-20
00810140062697RENPHOJoicom CorporationNGX2025-10-20
00810140062697RENPHOJoicom CorporationIPF2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.IPF2025-10-03
00810113683782ManaRecovery Stimulation System Manamed, Inc.NGX2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.NGX2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.IPF2025-10-03
00092237621967TwinStimDrive Devilbiss HealthcareNGX2025-09-29
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.IPF2025-09-11
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NGX2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.IPF2025-09-11
00810113683379DualPulse CompactManamed, Inc.IPF2025-09-11
00810113683386DualPulse Compact Replacement Gel PadManamed, Inc.IPF2025-09-11
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.NGX2025-08-21
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.IPF2025-08-21
00092237621974TwinStimDrive Devilbiss HealthcareNGX2025-08-15
00810188050052L360 Thigh SystemBioness Medical, Inc.IPF2025-07-18
00810188050175L100 Go SystemBioness Medical, Inc.IPF2025-07-18
00810188050441H200 Wireless SystemBioness Medical, Inc.IPF2025-07-18