FDA.reportPublic FDA data

SEIRIN PY-Zero

Primary DI
24547248423067
Brand
SEIRIN PY-Zero
Company
SEIRIN CORPORATION
Model
PY-Zero 0.3mm Ø9
Device description
PY-Zero is a non-invasive and stress-free acupressure device that stimulates through gentle pressing instead of a needle tip. The patented plastic case and sheath enable the practitioner to insert the needle without touching the needle tip or the surface of the Micropore adhesive tape. This hypoallergenic, latex-free adhesive allows the skin to breathe during treatment.
Published
2025-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNMDevice, Pressure Applying

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNMDevice, Pressure ApplyingPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14547248423060PackageGS110In Commercial Distribution
04547248423063PrimaryGS10
24547248423067Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1454724842306014547248423060
04547248423063045472484230634547248423063
2454724842306724547248423067

GMDN Terms#

Term, Definition table
TermDefinition
Acupressure applicator, single-useA small device intended for the application of noninvasive, non-powered acupressure to acupuncture points on the skin for the treatment of a variety of conditions/disorders. It is typically a polymer disc with a very short protruding metallic contact point, held on the skin with slight manual pressure. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length0.3Millimeter
Outer Diameter0.2Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800 722 8775customerservice@lhasaoms.com

Regulatory Flags#

DUNS number
693307373
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04547248021108SEIRIN ACUPUNCTURE NEEDLED-type (Dtype SP) No.1(0.16)x15mm2026-05-31
04547248021153SEIRIN ACUPUNCTURE NEEDLED-type (Dtype SP) No.2(0.18)x15mm2026-05-31
04547248021207SEIRIN ACUPUNCTURE NEEDLED-type (Dtype SP) No.3(0.20)x15mm2026-05-31
04547248021382SEIRIN ACUPUNCTURE NEEDLED-type (Dtype SP) No.5(0.25)x15mm2026-05-31
04547248022112SEIRIN ACUPUNCTURE NEEDLEJ-ProPak10 No.1(0.16)x30mm2026-05-31
04547248022211SEIRIN ACUPUNCTURE NEEDLEJ-ProPak10 No.3(0.20)x30mm2026-05-31
04547248024055SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.02(0.12)x30mm2026-05-31
04547248024062SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.02(0.12)x40mm2026-05-31
04547248024086SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.01(0.14)x30mm2026-05-31
04547248024093SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.01(0.14)x40mm2026-05-31
04547248024116SEIRIN ACUPUNCTURE NEEDLEJ-type(JSP type) No.1(0.16)x30mm2026-05-31
04547248024123SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.1(0.16)x40mm2026-05-31
04547248024130SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.1(0.16)x50mm2026-05-31
04547248024161SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.2(0.18)x30mm2026-05-31
04547248024178SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.2(0.18)x40mm2026-05-31
04547248024185SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.2(0.18)x50mm2026-05-31
04547248024215SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.3(0.20)x30mm2026-05-31
04547248024222SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.3(0.20)x40mm2026-05-31
04547248024239SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.3(0.20)x50mm2026-05-31
04547248024246SEIRIN ACUPUNCTURE NEEDLEJ-type(JSP type) No.3(0.20)x60mm2026-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04547248600020SEIRIN ShonishinSEIRIN CORPORATIONKNM2026-05-31
10885632465031HalyardOWENS & MINOR DISTRIBUTION, INC.KNM2026-01-22
20885632465038HalyardOWENS & MINOR DISTRIBUTION, INC.KNM2026-01-22
00818318025352iCare Vacuum Cupping SetPrime Holly CorporationKNM2025-05-16
10818318029081iCare Vacuum Cupping SetPrime Holly CorporationKNM2025-05-16
04547248423056SEIRIN PY-ZeroSEIRIN CORPORATIONKNM2025-03-03
04547248423063SEIRIN PY-ZeroSEIRIN CORPORATIONKNM2025-03-03
14547248423053SEIRIN PY-ZeroSEIRIN CORPORATIONKNM2025-03-03
06977182810113Shenzhen Wells Optoelectronics Co.,Ltd.Shenzhen Wells Optoelectronics Co.,Ltd.KNM2024-06-16
03760262490625BAT02 Glass rodsSEDATELECKNM2024-04-25
03760262490670EASYO 1 - Multi Pressure FeelerSEDATELECKNM2024-04-25
03760262492902PAL130 Pressure feeler 130gSEDATELECKNM2024-04-25
03760262492919PAL250 Pressure feeler 250gSEDATELECKNM2024-04-25
03760262492926PAL400 Pressure feeler 400gSEDATELECKNM2024-04-25
03760262492933PAL650 Pressure feeler 650gSEDATELECKNM2024-04-25
07350120791955KIWI DermaForeo ABKNM2024-03-11
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06901452150050HWATO Vacuum Cupping SetSuzhou Medical Appliance FactoryKNM2023-11-15
06901452150067HWATO Vacuum Cupping SetSuzhou Medical Appliance FactoryKNM2023-11-15
06901452150074HWATO Vacuum Cupping SetSuzhou Medical Appliance FactoryKNM2023-11-15
06901452150081HWATO Vacuum Cupping SetSuzhou Medical Appliance FactoryKNM2023-11-15
16901452983860HWATO Vaccaria seed W/P-50, with TapeSuzhou Medical Appliance FactoryKNM2023-10-10
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00840252904028Sensory VestTherafin CorporationKNM2023-07-06
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00840252904042Sensory CuffTherafin CorporationKNM2023-07-06