BITS Motion Sensor BITS-3355
by Bioness Inc.
BITS Motion Sensor BITS-3355 is a Class II device made by Bioness Inc., listed in FDA GUDID since 10 Aug 2020 (UDI-DI 00815962020634), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00815962020634 | Date10 Aug 2020 | StatusListed |
Official records
- AccessGUDID record 00815962020634
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- BITS Motion Sensor
- Generic name
- Perceptual-coordination assistive training device
- Model / reference
- BITS-3355
- Primary DI / UDI-DI
- 00815962020634
- FDA product code
- ISD, PTY, IKK
- GMDN term
- Perceptual-coordination assistive training device
- Device class
- Class II
- Regulation number
- 890.5360, 882.1470, 890.1925
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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