FDA UDI
In Commercial Distribution
🇺🇸 United States
Bioness Integrated Therapy System, BITS 3.0, BITS Balance
DI: 00810188050045
·
Model: BIT-3155
·
Bioness Medical, Inc.
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Bioness Integrated Therapy System, BITS 3.0, BITS Balance
- Primary DI
- 00810188050045
- Version / Model
- BIT-3155
- Company Name
- Bioness Medical, Inc.
- Labeler DUNS
- 119378513
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-18
- Public Version
- 1
- Public Version Date
- 2025-07-28
- Public Version Status
- New
- Public Device Record Key
- 188ab433-5802-481e-a3cc-5d2ffc62f0a8
Device Description
BITS PC Kit, BITS Balance Accessory Kit, and BITS Balance Platform Kit
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| IKK | System, Isokinetic Testing And Evaluation | Physical Medicine | 890.1925 | 2 |
| PTY | Computerized Cognitive Assessment Aid, Exempt | Neurology | 882.1470 | 2 |
| ISD | Exerciser, Measuring | Physical Medicine | 890.5360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30908 | Perceptual-coordination assistive training device | A device designed to help train a person with a disability to improve their ability to correctly process and coordinate external stimuli, especially those relating to concepts of space and time, spatial concepts, and eye-hand coordination. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810188050045 | GS1 | ||||
| Previous | 00815962020627 | GS1 |
Customer Contacts
- Phone
- +1(800)211-9136
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 176 Degrees Fahrenheit