TheraBite Jaw Motion Rehabilitation System, Pediatric TH002

GUDID 07331791004889

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. The TheraBite system is intended for single-patient use only

Atos Medical AB

Mastication muscle exerciser

Primary Device ID	07331791004889
NIH Device Record Key	b4f64a26-f2f2-4096-b516-08048019af9e
Commercial Distribution Status	In Commercial Distribution
Brand Name	TheraBite Jaw Motion Rehabilitation System, Pediatric
Version Model Number	TH002
Catalog Number	TH002
Company DUNS	355470923
Company Name	Atos Medical AB
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	true

Customer Support Contacts

Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com

Device Dimensions

Width	4.6 Centimeter
Width	4.6 Centimeter
Width	4.6 Centimeter
Width	4.6 Centimeter
Width	4.6 Centimeter
Width	4.6 Centimeter
Width	4.6 Centimeter
Width	4.6 Centimeter
Width	4.6 Centimeter
Width	4.6 Centimeter
Width	4.6 Centimeter
Width	4.6 Centimeter
Width	4.6 Centimeter
Width	4.6 Centimeter
Width	4.6 Centimeter
Width	4.6 Centimeter
Width	4.6 Centimeter
Width	4.6 Centimeter
Width	4.6 Centimeter
Width	4.6 Centimeter
Width	4.6 Centimeter
Width	4.6 Centimeter
Width	4.6 Centimeter
Width	4.6 Centimeter
Width	4.6 Centimeter
Width	4.6 Centimeter
Width	4.6 Centimeter
Width	4.6 Centimeter
Width	4.6 Centimeter
Width	4.6 Centimeter
Width	4.6 Centimeter
Width	4.6 Centimeter

Operating and Storage Conditions

Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07331791004889 [Primary]

FDA Product Code

ION	Exerciser, Non-Measuring

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-12-06
Device Publish Date	2022-11-28

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