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Bioness Integrated Therapy System, BITS 3.0, BITS Balance

FDA UDI

Class II (US FDA UDI)

by Bioness Medical, 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
BITS PC Kit, BITS Balance Accessory Kit, and BITS Balance Platform Kit FDA UDI
Model / Reference
BIT-3155 FDA UDI
Description
BITS PC Kit, BITS Balance Accessory Kit, and BITS Balance Platform Kit FDA UDI

Identifiers

Primary DI / UDI-DI
00810188050045 FDA UDI
FDA Product Code
IKK FDA UDI
PTY FDA UDI
ISD FDA UDI
GMDN Term
Perceptual-coordination assistive training device FDA UDI

Classification

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Perceptual-coordination assistive training device

Bioness Integrated Therapy System, BITS 3.0, BITS Balance by Bioness Medical, 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 Medical, Inc.

Sources (1)

  • FDA UDI 188ab433-5802-481e-a3cc-5d2ffc62f0a8 35 fields · synced Jun 9, 2026