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L360 Thigh System

FDA UDI

Class II (US FDA UDI)

by Bioness Medical, Inc.

Identity

Trade Name
L360 Thigh System FDA UDI
Generic Name
Gait-enhancement electrical stimulation system, external FDA UDI
Device Name
L360 Thigh System Kit, Right FDA UDI
Model / Reference
L4T-6000 FDA UDI
Description
L360 Thigh System Kit, Right FDA UDI

Identifiers

Primary DI / UDI-DI
00810188050052 FDA UDI
510(k) Number
K191587 FDA UDI
FDA Product Code
GZI FDA UDI
IPF FDA UDI
GMDN Term
Gait-enhancement electrical stimulation system, external FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5810 FDA UDI
890.5850 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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Gait-enhancement electrical stimulation system, external

L360 Thigh System by Bioness Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gait-enhancement electrical stimulation system, external.

Cleared under the same submission

K191587 also covers:

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 3b12af31-4bb4-4c1c-80bc-df542d6ab384 36 fields · synced Jun 9, 2026