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Bioness Integrated Therapy System, BITS 3.0, BITS Balance
FDA UDIClass II (US FDA UDI)
by Bioness Inc.
Identity
- Trade Name
- Bioness Integrated Therapy System, BITS 3.0, BITS Balance FDA UDI
- Generic Name
- Perceptual-coordination assistive training device FDA UDI
- Device Name
- Bioness Integrated Therapy System Version 3.0, Hardware It - 55" Display, BITS Software Kit, BITS PC Kit, BITS Balance Accessory Kit, and BITS Balance Platform Kit FDA UDI
- Model / Reference
- BITS-3055 FDA UDI
- Description
- Bioness Integrated Therapy System Version 3.0, Hardware It - 55" Display, BITS Software Kit, BITS PC Kit, BITS Balance Accessory Kit, and BITS Balance Platform Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815962020610 FDA UDI
- FDA Product Code
- PTY FDA UDIISD FDA UDIIKK FDA UDI
- GMDN Term
- Perceptual-coordination assistive training device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1470 FDA UDI890.5360 FDA UDI890.1925 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Perceptual-coordination assistive training device
Bioness Integrated Therapy System, BITS 3.0, BITS Balance by Bioness Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Perceptual-coordination assistive training device.
- Bioness Integrated System (BITS) Mobile Configuration — Bioness Medical, Inc. · Class II
- Flint Rehab — Flint Rehabilitation Devices, LLC · Class I
- Flint Rehab — Flint Rehabilitation Devices, LLC · Class I
- Flint Rehab — Flint Rehabilitation Devices, LLC · Class I
- Bioness Integrated Therapy System, BITS 3.0, BITS Balance — Bioness Medical, Inc. · Class II
- Flint Rehab — Flint Rehabilitation Devices, LLC · Class I
- Flint Rehab — Flint Rehabilitation Devices, LLC · Class I
- Flint Rehab — Flint Rehabilitation Devices, LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bioness Inc.
Sources (1)
- FDA UDI 9f7fa0eb-b7a0-46bb-8d91-780f9e4544be 35 fields · synced Jun 8, 2026