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BITS Motion Sensor

FDA UDI

Class II (US FDA UDI)

by Bioness Inc.

Identity

Trade Name
BITS Motion Sensor FDA UDI
Generic Name
Perceptual-coordination assistive training device FDA UDI
Device Name
Bioness Integrated Therapy System Version 3.0 Motion Sensor FDA UDI
Model / Reference
BITS-3355 FDA UDI
Description
Bioness Integrated Therapy System Version 3.0 Motion Sensor FDA UDI

Identifiers

Primary DI / UDI-DI
00815962020634 FDA UDI
FDA Product Code
ISD FDA UDI
PTY FDA UDI
IKK FDA UDI
GMDN Term
Perceptual-coordination assistive training device FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5360 FDA UDI
882.1470 FDA UDI
890.1925 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

No

FDA UDI

Combination Product

No

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
MRI Safety
MR Unsafe FDA UDI

Category: Perceptual-coordination assistive training device

BITS Motion Sensor 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bioness Inc.

Sources (1)

  • FDA UDI 21f14c18-be1e-4ad2-a53c-a5dfb0f9c180 35 fields · synced May 30, 2026