ReStore

FDA UDI

Class II (US FDA UDI)

by Lifeward, Inc.

Identity

Trade Name: ReStore FDA UDI
Generic Name: Programmable ambulation exoskeleton, clinical FDA UDI
Device Name: The device is a lightweight, wearable, battery-powered soft orthotic exosuit intended to be used to preform ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia / hemiparesis due to stroke. FDA UDI
Model / Reference: 50-40-0001 FDA UDI
Description: The device is a lightweight, wearable, battery-powered soft orthotic exosuit intended to be used to preform ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia / hemiparesis due to stroke. FDA UDI

Identifiers

Primary DI / UDI-DI: 00860001744507 FDA UDI
510(k) Number: K190337 FDA UDI
FDA Product Code: PHL FDA UDI
GMDN Term: Programmable ambulation exoskeleton, clinical FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.3480 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Programmable ambulation exoskeleton, clinical

ReStore by Lifeward, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Lifeward, Inc.

Sources (1)

FDA UDI 58b3baf7-e553-490e-a338-ec02cc3dfb42 34 fields · synced Jun 1, 2026