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

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Primary DI, Brand, Company table
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