FDA UDI
In Commercial Distribution
🇺🇸 United States
Movive Education Unit
DI: 00860001790832
·
Model: 005EDU
·
Medrhythms, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Movive Education Unit
- Primary DI
- 00860001790832
- Version / Model
- 005EDU
- Company Name
- Medrhythms, Inc.
- Labeler DUNS
- 080565076
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-13
- Public Version
- 2
- Public Version Date
- 2026-03-17
- Public Version Status
- Update
- Public Device Record Key
- 57d50a52-0d4f-4f93-923b-70a682fbd213
Device Description
Education Unit for Movive
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
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 63475 | Physical/neuromuscular rehabilitation software | A software program intended to help a patient regain functional physical and/or neuromuscular control through guided activities (e.g., physiotherapy exercises, visuomotor stimulating onscreen patterns, interactive games, speech exercises), in cases of musculoskeletal, neurological, and/or oral-motor conditions/events (e.g., trauma, Parkinson’s, stroke, traumatic brain injury). It is intended to be used in the home on a non-medical device (e.g., tablet, smartphone, computer); it is not intended to interface with external biomechanical function analysis equipment. Some types involve clinical supervision or consultation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860001790832 | GS1 |