Restore Skills Therapy

GUDID G629RESTORESKILLSTHERA0

Interactive rehabilitation exercise device, prescription use

TIMOCCO USA, INC.

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Primary Device ID	G629RESTORESKILLSTHERA0
NIH Device Record Key	b0a4b9d4-7693-435f-b8c9-dcaa7e290eea
Commercial Distribution Status	In Commercial Distribution
Brand Name	Restore Skills Therapy
Version Model Number	1
Company DUNS	090141480
Company Name	TIMOCCO USA, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G629RESTORESKILLSTHERA0 [Primary]

FDA Product Code

QKC	Interactive Rehabilitation Exercise Device, Prescription Use

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-07-05
Device Publish Date	2024-06-27