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ODFS Pace XL

FDA UDI

Class II (US FDA UDI)

by Odstock Medical, Ltd.

Identity

Trade Name
ODFS Pace XL FDA UDI
Generic Name
Gait-enhancement electrical stimulation system, external FDA UDI
Device Name
Single channel, transcutaneous neuromuscular stimulator for relief of dropped foot. Also cleared for gait re-education and similar applications plus physical therapy uses. FDA UDI
Model / Reference
1.1 FDA UDI
Description
Single channel, transcutaneous neuromuscular stimulator for relief of dropped foot. Also cleared for gait re-education and similar applications plus physical therapy uses. FDA UDI

Identifiers

Catalog Number
00-001-0019 FDA UDI
Primary DI / UDI-DI
05060195470441 FDA UDI
510(k) Number
K171396 FDA UDI
FDA Product Code
IPF FDA UDI
GZI FDA UDI
GMDN Term
Gait-enhancement electrical stimulation system, external FDA UDI

Classification

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Gait-enhancement electrical stimulation system, external

ODFS Pace XL by Odstock Medical, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Odstock Medical, Ltd.

Sources (1)

  • FDA UDI 922ec1aa-5358-4c95-9862-49b8a895956e 36 fields · synced Jun 8, 2026