AccessGUDID - DEVICE: ARMEDICA (B866MAMTM7061)

GUDID

Device Identifier (DI) Information

Brand Name: ARMEDICA
Version or Model: AMTM706
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AMTM706
Company Name: ARMEDICA MANUFACTURING CORP.

Primary DI Number: B866MAMTM7061
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 018941711 *Terms of Use

Device Description: LAMINATED SPLIT PLATFORM MOUNTED, ELECTRIC 10 FT BARIATRIC PARALLEL BARS WITH END CONTROLS

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):	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?
46339	Parallel bar exerciser, powered	A mains electricity (AC-powered) exercise apparatus designed to assist a user in maintaining good walking posture, particularly a person with a disability, a paraplegic, or a patient who has suffered a stroke and is learning to walk. It typically consists of two parallel wooden or steel handrails each one supported by two poles and base plates; the user holds the bars, which are electrically height and/or width-adjustable, thus relieving his/her weight when walking. The device is intended to improve the user?s balance as well as coordination and flexibility; additionally, it can improve the muscle strength in the lower limbs.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IOE	Bars, Parallel, Exercise

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: 32dd6c10-872e-4b91-a6ef-b191012a98fd
Public Version Date: November 28, 2022
Public Version Number: 1
DI Record Publish Date: November 18, 2022