AccessGUDID - DEVICE: SaeboRejoyce (00850331006567)

GUDID

Device Identifier (DI) Information

Brand Name: SaeboRejoyce
Version or Model: SaeboRejoyce
Commercial Distribution Status: In Commercial Distribution
Catalog Number: K4-RJ-10---1
Company Name: SAEBO, INC.

Primary DI Number: 00850331006567
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 168569098 *Terms of Use

Device Description: Virtual-display arm rehabilitation system

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58060	Virtual-display arm rehabilitation system, non-gravity-compensating	An assembly of devices designed to provide non-gravity-compensating therapy for a patient who has lost motor function of the arm(s), caused by cerebral, neurogenic, spinal, muscular or bone-related disorders, through interaction with a software program prompting repeated motion of the arms, fingers, and hands to improve reaching/grasping mobility. It consists of an infrared (IR) tracking camera, patient data gloves with integrated IR-emitting sensors, visual display unit (VDU), and computer-calculated arm/finger position and training software. It is used for inpatients, outpatients or home settings for patients able to understand and interact with the audio-visual instructions.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
IKK	System, Isokinetic Testing And Evaluation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ad1da9fd-809c-43f7-8848-0f46071b9ff8
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 26, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 888-284-5433
Email: Info@saebo.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES