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Bioness Integrated System (BITS)2.0.5

FDA UDI

Class II (US FDA UDI)

by Bioness Inc.

Identity

Trade Name
Bioness Integrated System (BITS)2.0.5 FDA UDI
Generic Name
Perceptual-coordination assistive training device FDA UDI
Model / Reference
2.0.1 FDA UDI

Identifiers

Primary DI / UDI-DI
00815962020054 FDA UDI
FDA Product Code
IKK FDA UDI
GMDN Term
Perceptual-coordination assistive training device FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
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

Yes

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

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Perceptual-coordination assistive training device

Bioness Integrated System (BITS)2.0.5 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 f0d2d7db-01c1-4857-ac09-43e3d212dbed 33 fields · synced May 30, 2026