FDA UDI
In Commercial Distribution
🇺🇸 United States
Quantum Mitohormesis (QMT)
DI: 08885022060018
·
Model: M2101
·
QUANTUMTX PTE. LTD.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Quantum Mitohormesis (QMT)
- Primary DI
- 08885022060018
- Version / Model
- M2101
- Company Name
- QUANTUMTX PTE. LTD.
- Labeler DUNS
- 659470592
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-21
- Public Version
- 1
- Public Version Date
- 2025-07-29
- Public Version Status
- New
- Public Device Record Key
- 7385c694-4d3e-4013-a6e6-3ee97a861b72
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | Physical Medicine | 890.5850 | 2 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | Physical Medicine | 890.5850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67593 | Muscle performance enhancement electromagnetic stimulator | An 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 18885022060015 | GS1 | BOX | 1 | In Commercial Distribution | |
| Primary | 08885022060018 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240348 | 000 |