M.A.S.S. Strap
- Primary DI
- G505MRMS0
- Brand
- M.A.S.S. Strap
- Company
- M.A.S.S. Rehab, LLC
- Model
- Standard
- Device description
- Simple two-loop spotting harness for gait and balance training.
- Published
- 2023-08-01
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| ION | Exerciser, Non-Measuring |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| ION | Exerciser, Non-Measuring | Physical Medicine | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| G505MRMS0 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Gait rehabilitation system harness | A lifting device, in the form of belts and straps, which is a component of a gait rehabilitation system designed to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) regain lost motor function. The device is designed to be secured around the patient?s upper body and hips and is intended to help suspend the patient vertically over the floor or a treadmill while attached to the supporting frame of a suspension device; it may be used in conjunction with a robotic orthosis device for the training of normal gait. |
Regulatory Flags
- DUNS number
- 603101416
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| G505MRBHS0 | Balance Harness | Standard | | 2023-08-01 |
| G505MRES0 | Easy Step | Standard | | 2023-08-01 |
| G505MRHSH0 | Healing Solutions Harness | Standard | | 2023-08-01 |
| G505MRPH0 | Pediatric Harness | Standard | | 2023-08-01 |
| G505MRST0 | Slip Trainer | Standard | | 2023-08-01 |
| G505MRTB0 | M.A.S.S. Traction Belt | Standard | | 2023-08-01 |
| G505MRUHB0 | Unloading Harness Bariatric | Bariatric | | 2023-08-01 |
| G505MRUHS0 | Unloading Harness | Standard | | 2023-08-01 |
Other Devices Sharing Product Codes