AccessGUDID - DEVICE: Vector 1 (B770VEC0)

GUDID

Device Identifier (DI) Information

Brand Name: Vector 1
Version or Model: Vector 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Vector 1
Company Name: LANTZ MEDICAL, INC.

Primary DI Number: B770VEC0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 614335276 *Terms of Use

Device Description: Exerciser to increase flexion and the extension range of motion of the joints of the second to the fifth fingers of the hand

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):	Yes
Over the Counter (OTC):	No
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?
17137	Hand/wrist continuous passive motion exerciser	A mains electricity (AC-powered) device designed to continuously move the metacarpal/interphalangeal joints (e.g., flexion and extension) without patient assistance during continuous passive motion (CPM) exercise therapy usually following surgery or trauma to the joints. It typically consists of a motorized carriage with straps to hold and move the hand/wrist, and an electrical control unit for the healthcare professional to set the variable range of motion and motion speed; digital displays, manual/automated safety capabilities, and other features may also be included. CPM is believed to stimulate articular tissues and circulation of synovial fluid, and to reduce joint oedema.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JFA	Exerciser, Finger, Powered

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: 62474b94-2c10-4f93-9aac-644b889c4388
Public Version Date: December 16, 2022
Public Version Number: 1
DI Record Publish Date: December 08, 2022