FDA.reportPublic FDA data

OraStretch® Press Device – Pediatric

Primary DI
00850056079037
Brand
OraStretch® Press Device – Pediatric
Company
Cranio Mandibular Rehab, Inc.
Model
CR1005
Device description
The OraStretch press system is indicated for individuals with, or at risk of trismus (limited oral opening) or jaw dysfunction. The appliance may also be used for physical therapy or rehabilitation of the mouth, jaw, or other orofacial tissues. The device is for single-patient use only. The Pediatric size is generally for patients under 10 years-old.
Published
2023-10-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
00850056079037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850056079037008500560790378500560790370850056079037

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width45Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-206-8381support@craniorehab.com

Regulatory Flags#

DUNS number
048276773
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850056079051OraStretch® Bitepad Pack – StandardCR10502024-04-01
00850056079068OraStretch® Bitepad Pack – StandardCR10552024-04-01
00850056079075OraStretch® Bitepad Pack – StandardCR10572024-04-01
00850056079082OraStretch® Power Band PackCR1070CR10702024-04-01
00850056079099OraStretch® Jaw ROM Scale PackCR1080CR10802024-04-01
00850056079105OraStretch® Deflection Deviation ScalesCR1083CR10832024-04-01
00850056079129OraStretch® Jaw MIO Plastic ScaleCR1087CR10872024-04-01
00850056079136OraMPA™ Microstomia ApplianceCR17302024-04-01
00850056079143OraMPA™ Microstomia Appliance - Severe Extra SmallCR17352024-04-01
00850056079150OraMPA™ Dynamic Band PackCR17412024-04-01
00850056079167OraMPA™ Static Wrap PackCR17432024-04-01
00850056079396OraStretch® Jaw MIO Scale PackCR1085CR10852024-04-01
00850056079402OraMPA™ Microstomia Appliance - XL Semi-CircumferentialCR17332024-04-01
00850056079006OraStretch® Press Device – StandardCR10002023-10-05
00850056079020OraStretch® Press Device – AnteriorCR10032023-10-05
00850056079044OraStretch® Extended Clip-On MouthpieceCR1007CR1007X2023-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09120077180311Elvistyromotion GmbHION2026-08-03
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08054040402876BIKOORMESA SRLION2026-08-01
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00851232007738OxyBREATH NON-MEASURING EXERCISERD R BURTON HEALTHCARE, LLCION2026-04-28
00851232007745OxyTrainer ADVANTAGED R BURTON HEALTHCARE, LLCION2026-04-28
08018294018009AirFeel IMTFLAEM NUOVA SPAION2026-02-18
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00860014768620MouthflexINNOMOTIVE L.L.CION2026-02-11
08054040402029FRAME RUNNERORMESA SRLION2025-10-15
08054040402036FRAME RUNNERORMESA SRLION2025-10-15
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