FDA.reportPublic FDA data

TheraBite Range of Motion Scale (150 pcs)

Primary DI
07331791004865
Brand
TheraBite Range of Motion Scale (150 pcs)
Company
Atos Medical AB
Model
SC001
Catalog number
SC001
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.
Published
2022-11-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IONExerciser, Non-Measuring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IONExerciser, Non-MeasuringPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07331791004865PrimaryGS10
07331791016622Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07331791004865073317910048657331791004865
07331791016622073317910166227331791016622

GMDN Terms#

Term, Definition table
TermDefinition
Mastication muscle exerciserAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from rain. Keep away from sunlight.
Storage Environment Temperature2 Degrees Celsius42 Degrees Celsius
Storage Environment Temperature36 Degrees Fahrenheit108 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+4641519800info@atosmedical.com

Regulatory Flags#

DUNS number
355470923
Device count
150
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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Primary DI, Brand, Model table
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07331791001703Provox XtraBase Adhesive726572652022-07-13
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07331791009525Provox Adhesive Strip801580152022-07-13
07331791014420Provox Life Standard Adhesive Round746074602022-07-13
07331791014437Provox Life Standard Adhesive Oval746174612022-07-13
07331791014444Provox Life Standard Adhesive Plus746274622022-07-13
07331791014451Provox Life Sensitive Adhesive Round746374632022-07-13
07331791014468Provox Life Sensitive Adhesive Oval746474642022-07-13
07331791014475Provox Life Sensitive Adhesive Oval B746574652022-07-13
07331791014482Provox Life Sensitive Adhesive Plus746674662022-07-13
07331791014499Provox Life Stability Adhesive826382632022-07-13

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