FDA.reportPublic FDA data

Foot Switch (HRF-M5 PS)

Primary DI
06971176283570
Brand
Foot Switch (HRF-M5 PS)
Company
Zhuhai Pusen Medical Technology Co, Ltd
Model
HRF-M5 PS
Device description
The Foot Switch (model: HRF-M5 PS) is an accessory for the Medical Video Endoscope Image Processor.
Published
2026-01-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FAJCystoscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222602000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222602000Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300)Zhuhai Pusen Medical Technology Co., Ltd.2022-09-26FAJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971176283570PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971176283570069711762835706971176283570

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image processing unitAn electrically-powered device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544427443
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971176281729EviewPV3002026-01-22
06971176281965EviewPVX8002026-01-22
06971176282399EviewPV2202026-01-22
06971176282924Single Use Video Ureteroscope Direct In-Scope SuctionPU630A-S2026-01-13
06971176282931Single Use Video Ureteroscope Direct In-Scope SuctionPU630A-R2026-01-13
06971176282955Single Use Flexible Video UreteroscopePU631A-R2026-01-13
06971176282962Single Use Video Ureteroscope Direct In-Scope SuctionPU632A-S2026-01-13
06971176282986Single Use Flexible Video UreteroscopePU633A-S2026-01-13
06971176282993Single Use Flexible Video UreteroscopePU633A-R2026-01-13
16971176282921Single Use Video Ureteroscope Direct In-Scope SuctionPU630A-S2026-01-13
16971176282938Single Use Video Ureteroscope Direct In-Scope SuctionPU630A-R2026-01-13
06971176282948Single Use Flexible Video UreteroscopePU631A-S2026-01-13
16971176282952Single Use Flexible Video UreteroscopePU631A-R2026-01-13
16971176282969Single Use Video Ureteroscope Direct In-Scope SuctionPU632A-S2026-01-13
06971176282979Single Use Video Ureteroscope Direct In-Scope SuctionPU632A-R2026-01-13
16971176282983Single Use Flexible Video UreteroscopePU633A-S2026-01-13
16971176282990Single Use Flexible Video UreteroscopePU633A-R2026-01-13
06971176281828Single Use Video Ureteroscope Direct In-Scope SuctionPU3033AH-S2025-10-17
06971176281835Single Use Video Ureteroscope Direct In-Scope SuctionPU3033AH-R2025-10-17
06971176281842Single Use Video Ureteroscope Direct In-Scope SuctionPU3033H-R2025-10-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826926952PENTAX MedicalPENTAX MEDICAL CORPORATIONFAJ2026-08-25
06975339621506BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621513BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621520BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621537BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621926BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621933BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621964BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621971BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
00850023925442WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925459WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925466WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925473WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925558WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925565WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925572WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925589WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925596WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925909WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925916WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925923WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925930WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925954WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925985WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925992WiScope®Otu Medical Inc.FAJ2026-07-28
06972084140498WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140504WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140511WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140528WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140597WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28