Restore Skills Therapy

GUDID G629RESTORESKILLSTHERA0

Interactive rehabilitation exercise device, prescription use

TIMOCCO USA, INC.

Virtual-display routine exercise software
Primary Device IDG629RESTORESKILLSTHERA0
NIH Device Record Keyb0a4b9d4-7693-435f-b8c9-dcaa7e290eea
Commercial Distribution StatusIn Commercial Distribution
Brand NameRestore Skills Therapy
Version Model Number1
Company DUNS090141480
Company NameTIMOCCO USA, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCG629RESTORESKILLSTHERA0 [Primary]

FDA Product Code

QKCInteractive Rehabilitation Exercise Device, Prescription Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-05
Device Publish Date2024-06-27

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