FDA.reportPublic FDA data

AquaWing

Primary DI
07540198003009
Brand
AquaWing
Company
Prime Pacific Health Innovations Corporation
Model
AquaWing
Catalog number
4200
Device description
The AquaWing is a treatment table intended to be used as a support for patients who are undergoing colon hydrotherapy.
Published
2023-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KMNChair And Table, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMNChair And Table, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540198003009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540198003009075401980030097540198003009

GMDN Terms#

Term, Definition table
TermDefinition
Examination/treatment table, manualA non-mobile table designed for routine/minor medical examinations and/or treatment of the patient. It will typically consist of a framework with a flat table top surface which may have a head section that can be manually adjusted into a raised position. The height of the table may also be manually adjusted to fixed positions (i.e., set to an initial height but not readily adjustable). It may facilitate a paper roll holder from which paper is pulled to cover the table surface as a hygienic barrier for each new patient. This device is typically used in examination rooms or doctors' surgeries as a statically placed table.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
250896255
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540198001005Pro-FitRegular Kit with stop disc81162016-09-23
07540198001012Pro-FitSmall Kit with stop disc81172016-09-23
07540198001029Pro-FitRegular Kit with guide rings81432016-09-23
07540198001036Pro-FitSmall Kit with guide rings81442016-09-23
07540198001067Pro-Fit Eco-FlexRegular Kit with stop disc8116-EF2016-09-23
07540198001111Pro-Fit Eco-FlexSmall Kit with stop disc8117-EF2016-09-23
07540198001166Pro-Fit Eco-FlexRegular Kit with guide rings8143-EF2016-09-23
07540198001210Pro-Fit Eco-FlexSmall Kit with guide rings8144-EF2016-09-23
07540198001241Pro-FitUniversal Kit91252016-09-23
07540198001272Pro-Fit Eco-FlexUniversal Kit9125-EF2016-09-23
07540198000305Pro-FitSmall Speculum Pack with stop disc81142016-09-30
07540198000312Pro-FitSmall Speculum Pack with stop disc81142016-09-30
07540198000329Pro-FitRegular Speculum Pack with stop disc81152016-09-30
07540198000336Pro-FitRegular Speculum Pack with stop disc81152016-09-30
07540198000343Pro-FitSmall Speculum Pack with guide rings81412016-09-30
07540198000350Pro-FitSmall Speculum Pack with guide rings81412016-09-30
07540198000367Pro-FitRegular Speculum Pack with guide rings81422016-09-30
07540198000374Pro-FitRegular Speculum Pack with guide rings81422016-09-30
07540198000381Pro-FitUniversal Speculum Pack91262016-09-30
07540198000398Pro-FitUniversal Speculum Pack91262016-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974847962736JEDHebei Jiede Medical Equipment Co., Ltd.KMN2026-06-04
09421905187770Adept Medical Retrograde IR Platform - Narrow + ExtensionADEPT MEDICAL LIMITEDKMN2026-02-09
09421905187787Adept Medical IR Platform Extension - NarrowADEPT MEDICAL LIMITEDKMN2026-02-09
06973134775172silverfoxSilverfox Corporation LimitedKMN2026-02-05
06970006390105DAYANGGuangdong Dayang Medical Technology Co.,LtdKMN2025-11-20
06974665668216SCIANYongkang Youha Electric Appliance Co.,LtdKMN2025-09-10
06974665668384SCIANYongkang Youha Electric Appliance Co.,LtdKMN2025-09-10
00860014524400MP SeatingMP SEATING INCKMN2025-08-19
00860014524417MP SeatingMP SEATING INCKMN2025-08-19
06973134775165silverfoxSilverfox Corporation LimitedKMN2025-07-09
B845CBZ0411WOTUREIntco Medical Industries, Inc.KMN2025-03-28
B845CBZ0413WOTUREIntco Medical Industries, Inc.KMN2025-03-28
09421905187749Adept Medical Retrograde IR Platform - NarrowADEPT MEDICAL LIMITEDKMN2025-03-21
B845CBZ041WOTUREIntco Medical Industries, Inc.KMN2025-03-20
00854798000380Changing TablePIVOTAL HEALTH SOLUTIONS, INC.KMN2025-03-07
00854798000410Changing TablePIVOTAL HEALTH SOLUTIONS, INC.KMN2025-03-07
00815067013395PROBASICSDrive Devilbiss HealthcareKMN2025-01-20
G53312170La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53312370La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53313170La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53313370La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53320420La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53320470La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53321250La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53321270La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53321420La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53321470La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53332170La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53333170La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21
G53342170La-Z-Boy Healthcare Knu ComfortKnu, LLCKMN2024-06-21