AccessGUDID - DEVICE: TheraBite Range of Motion Scale (150 pcs) (07331791004865)

GUDID

Device Identifier (DI) Information

Brand Name: TheraBite Range of Motion Scale (150 pcs)
Version or Model: SC001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SC001
Company Name: Atos Medical AB

Primary DI Number: 07331791004865
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 150
Labeler D-U-N-S® Number*: 355470923 *Terms of Use

Device Description: The Range of Motion Scale is used to monitor the progress of the jaw motion rehabilitation program. The TheraBite Jaw Motion Rehabilitation System is indicated for individuals who have, or are at risk of developing trismus, (restrictions in their ability to open their jaw), and/or experience pain in the joints and/or muscles of the jaw. The device can also be used as a rehabilitation tool for postoperative physical therapy of the jaw, or to maintain the mouth open in a stable position, for example while performing dysphagia exercises.

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:	Yes
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?
17802	Mastication muscle exerciser	An intraoral mechanical exercise apparatus intended primarily to strengthen and rehabilitate the jaw muscles of mastication of a patient who has pain in, or disorders of, the temporomandibular joint (TMJ), typically through repetitive biting against resistive forces provided by the device. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ION	Exerciser, Non-Measuring

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
Storage Environment Temperature: between 36 and 108 Degrees Fahrenheit
Special Storage Condition, Specify: Keep away from rain. Keep away from sunlight.
Storage Environment Temperature: between 2 and 42 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5c2ccb90-fd1c-4c4d-81d9-992b1a15d139
Public Version Date: November 25, 2024
Public Version Number: 4
DI Record Publish Date: November 29, 2022