FDA.reportPublic FDA data

ChoiceMMed

Primary DI
00846841030147
Brand
ChoiceMMed
Company
Beijing Choice Electronic Technology Co., Ltd.
Model
MD8000
Device description
ChoiceMMed LungBoost Respiratory Trainer MD8000
Published
2020-08-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00846841030147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846841030147008468410301478468410301470846841030147

GMDN Terms#

Term, Definition table
TermDefinition
Respiratory muscle training maskA mask placed over the nose/mouth designed to create resistance for a patient's airway while inhaling and/or exhaling during respirations to strengthen and rehabilitate the respiratory muscles. It typically creates resistance through a mechanical means (e.g., a spring-loaded valve) that can be adjusted to provide progressive training. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
526882823
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06942820462535BLUE JAYBJ2401052026-01-23
00846841010262mibestCHP1C12021-09-24
00846841010279mibestCHP1C1-Gel2021-09-24
06942820462511VIEW O2180-50572025-12-23
06942820462528OxywatchDSI-DSFP-22025-12-23
00846841092527ChoiceMMedOxyWatch C292025-09-29
00846841092695ChoiceMMedMD300CN568R2025-09-24
00846841060830Henry Schein112-70632016-09-29
00846841060724ChoiceMMedMDN1042018-05-29
00846841060762ChoiceMMedMDN1052016-09-28
00846841092596mibestIBH-0012025-07-23
00846841091599mibestMD300C572025-07-22
00846841092565ChoiceMMedMD300CI218R2025-07-22
00846841092701mibestMD300C562025-07-22
00846841092947ChoiceMMedOxyWatch C2052025-07-22
00846841092954ChoiceMMedMD300CN550R2025-07-22
06942820462504Choicemmed MD300W6282025-07-22
00846841092589mibestNA-0022025-07-18
06942820462368ChoicemmedMD300CI218R2025-04-27
06942820462375ChoicemmedMD300CI216R2025-04-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09120077180311Elvistyromotion GmbHION2026-08-03
08054040401879BIKOORMESA SRLION2026-08-01
08054040401886BIKOORMESA SRLION2026-08-01
08054040401893BIKOORMESA SRLION2026-08-01
08054040401909BIKOORMESA SRLION2026-08-01
08054040401916BIKOORMESA SRLION2026-08-01
08054040401923BIKOORMESA SRLION2026-08-01
08054040401930BIKOORMESA SRLION2026-08-01
08054040401947BIKOORMESA SRLION2026-08-01
08054040401954BIKOORMESA SRLION2026-08-01
08054040401961BIKOORMESA SRLION2026-08-01
08054040401978BIKOORMESA SRLION2026-08-01
08054040401985BIKOORMESA SRLION2026-08-01
08054040401992BIKOORMESA SRLION2026-08-01
08054040402005BIKOORMESA SRLION2026-08-01
08054040402876BIKOORMESA SRLION2026-08-01
08054040403729BIKOORMESA SRLION2026-08-01
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