FDA UDI
In Commercial Distribution
🇺🇸 United States
AlterG Anti-Gravity Treadmill
DI: 00850022788017
·
Model: Fit X
·
Alterg, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AlterG Anti-Gravity Treadmill
- Primary DI
- 00850022788017
- Version / Model
- Fit X
- Company Name
- Alterg, Inc.
- Labeler DUNS
- 614284649
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-06
- Public Version
- 1
- Public Version Date
- 2020-10-14
- Public Version Status
- New
- Public Device Record Key
- 71723577-6647-4e7e-8cea-62da665f98f2
Device Description
The Fit X Anti-Gravity Treadmill is intended to be an entry level product used in a clinical setting for standing, walking, or running in place for rehabilitation, or conditioning for individuals that may require or benefit from the use of body weight support
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 |
|---|---|---|---|---|
| BXB | Exerciser, Powered | Physical Medicine | 890.5380 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61495 | Pneumatic-support treadmill | A mains electricity (AC-powered) device intended to create an anti-gravity effect to facilitate standing and in-place walking or running of a patient with a lower extremity injury/disorder during rehabilitation; it may also be used for obesity weight reduction and to help improve cardiovascular fitness. It consists of a speed-regulated treadmill (an endless, shock-absorbing rubber belt rotating on rollers); an air-inflatable chamber intended to encircle the patient’s lower body to provide pressure for weight support; an operator control unit to regulate treadmill speed/elevation and air-pressure weight support level; and side-mounted rails for the patient to hold for stabilization. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850022788017 | GS1 |
Customer Contacts
- Phone
- +1 5102705900
- [email protected]