FDA UDI
In Commercial Distribution
🇺🇸 United States
Slip Trainer
DI: G505MRST0
·
Model: Standard
·
M.A.S.S. Rehab, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Slip Trainer
- Primary DI
- G505MRST0
- Version / Model
- Standard
- Company Name
- M.A.S.S. Rehab, LLC
- Labeler DUNS
- 603101416
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-01
- Public Version
- 1
- Public Version Date
- 2023-08-09
- Public Version Status
- New
- Public Device Record Key
- cfadfa0a-0d84-41b5-ab3b-b213be672f5e
Device Description
Perturbation training device.
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
- No
- 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 |
|---|---|---|---|---|
| ION | Exerciser, Non-Measuring | Physical Medicine | 890.5370 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44240 | Balance board | A flat, rigid beam that is placed on the floor and upon which a patient with difficulties in balance (e.g., a paraplegic or a stroke victim) walks for balance training. It is slightly elevated off of the floor and is available in various widths; some types may provide a motion (e.g., rock) to increase the level of difficulty. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G505MRST0 | HIBCC |