FDA.reportPublic FDA data

OraMPA™ Microstomia Appliance - Severe Extra Small

Primary DI
00850056079143
Brand
OraMPA™ Microstomia Appliance - Severe Extra Small
Company
Cranio Mandibular Rehab, Inc.
Model
CR1735
Device description
The OraMPA™ Microstomia Appliance stretches the lips to prevent and treat microstomia. This version is for extreme microstomia.
Published
2024-04-01
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
00850056079143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850056079143008500560791438500560791430850056079143

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.

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
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
00850056079037OraStretch® Press Device – PediatricCR10052023-10-05
00850056079044OraStretch® Extended Clip-On MouthpieceCR1007CR1007X2023-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851232007738OxyBREATH NON-MEASURING EXERCISERD R BURTON HEALTHCARE, LLCION2026-04-28
00851232007745OxyTrainer ADVANTAGED R BURTON HEALTHCARE, LLCION2026-04-28
08018294018009AirFeel IMTFLAEM NUOVA SPAION2026-02-18
18018294018006AirFeel IMTFLAEM NUOVA SPAION2026-02-18
00860014768620MouthflexINNOMOTIVE L.L.CION2026-02-11
08054040402029FRAME RUNNERORMESA SRLION2025-10-15
08054040402036FRAME RUNNERORMESA SRLION2025-10-15
08054040401275FRAME RUNNERORMESA SRLION2025-09-20
08054040401282FRAME RUNNERORMESA SRLION2025-09-20
08054040401299FRAME RUNNERORMESA SRLION2025-09-20
08054040401305FRAME RUNNERORMESA SRLION2025-09-20
08054040401312FRAME RUNNERORMESA SRLION2025-09-20
08054040401329FRAME RUNNERORMESA SRLION2025-09-20
08054040401336FRAME RUNNERORMESA SRLION2025-09-20
08054040401343FRAME RUNNERORMESA SRLION2025-09-20
08054040401350FRAME RUNNERORMESA SRLION2025-09-20
08054040401367FRAME RUNNERORMESA SRLION2025-09-20
08054040401374FRAME RUNNERORMESA SRLION2025-09-20
08054040401381FRAME RUNNERORMESA SRLION2025-09-20
08054040401398FRAME RUNNERORMESA SRLION2025-09-20
08054040401404FRAME RUNNERORMESA SRLION2025-09-20
08054040401411FRAME RUNNERORMESA SRLION2025-09-20
08054040401428FRAME RUNNERORMESA SRLION2025-09-20
08054040401435FRAME RUNNERORMESA SRLION2025-09-20
08054040401442FRAME RUNNERORMESA SRLION2025-09-20
00384703160019EmpelvicOWEN MUMFORD USA INCORPORATEDION2025-08-22
00384703150010EmpelvicOWEN MUMFORD USA INCORPORATEDION2025-08-22
00384703155015EmpelvicOWEN MUMFORD USA INCORPORATEDION2025-08-22
00810188050557Vector BaseBioness Medical, Inc.ION2025-07-18
00616784050010Pedal Exerciser, Non-Folding, Hands/FeetDynarex CorporationION2025-05-29