FDA UDI
In Commercial Distribution
🇺🇸 United States
LIFE System
DI: 00852168008004
·
Model: Pro Plus
·
HARMONIC ENERGETIC TECH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LIFE System
- Primary DI
- 00852168008004
- Version / Model
- Pro Plus
- Company Name
- HARMONIC ENERGETIC TECH
- Labeler DUNS
- 062421553
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-05
- Public Version
- 1
- Public Version Date
- 2026-03-13
- Public Version Status
- New
- Public Device Record Key
- 0702af6f-8b34-432f-98c4-0c7c811efa12
Device Description
The L.I.F.E. System is a professional biofeedback device designed to detect stress and energetic imbalances, providing real-time feedback to support relaxation, wellness, and self-regulation.
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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| HCC | Device, Biofeedback | Neurology | 882.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44574 | Biofeedback system application software | An application software program designed for use in, or together with, a biofeedback system, so that it may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00852168008004 | GS1 |