FDA.reportPublic FDA data

Pixie Cup

Primary DI
00850016867209
Brand
Pixie Cup
Company
Pixie Cup LLC
Model
B09NQDYZMW
Device description
Pixie Pulse - Pixie Period Pain Relief Device
Published
2025-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850016867209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850016867209008500168672098500168672090850016867209

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous blood irradiation laserA battery-powered wearable device designed to emit low-intensity laser light (e.g., wavelength of 650 nm) for the transcutaneous irradiation of blood and tissues to improve haemodynamic and metabolic parameters (e.g., increased blood oxygen capacity and red blood cell deformability, reduced blood viscosity and blood pressure, improved blood glucose/lipids). It is intended for home-use and is typically worn on the wrist to irradiate the radial artery and NeiGuan points (medial forearm); it may include an external nasal sinus probe intended to treat rhinitis and sinusitis.

Contacts#

Phone, Email table
PhoneEmail
4172430677info@pixiecup.com

Regulatory Flags#

DUNS number
028513002
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850068130863Pixie CupB0GMXXDH8J2026-03-19
00850068130870Pixie CupB0GMT9C1KH2026-03-19
00850068130887Pixie CupB0GMVH5VXD2026-03-19
00850068130894Pixie CupB0GMTK2PST2026-03-19
00850068130900Pixie CupB0GMTQHF3Z2026-03-19
00850068130917Pixie CupB0GMSQ371C2026-03-19
00850068130924Pixie CupB0GMTGNF1M2026-03-19
00850068130931Pixie CupB0GMT62Y3Y2026-03-19
00850068130948Pixie CupB0GMSKKK1S2026-03-19
00715875074840Pixie CupM2506PC1915A2025-06-25
00869352000324Pixie CupB019632Z0E2023-09-28
00850016867407Pixie CupB0BFNLQC4L2026-01-09
00850016867254Pixie CupB09Y8YP43N2023-09-28
00869352000317Pixie CupB0197T6IEQ2023-09-28
00850068130221Pixie CupB0FJBG2VVN2025-08-02
00850016867780Pixie CupM2506PD2023A2025-06-24
00860417001393Pixie CupM2506PD2020A2025-06-26
00869352000348Pixie Cup250708G0032025-06-26
00850016867742Pixie CupM2506PC1911A2025-06-25
00850016867926Pixie CupB0DBVXH8NL 2024-11-12

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Primary DI, Brand, Company table
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00850080988145AUVONUAN HEALTHCARE LIMITEDNUH2026-03-23
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00850073128169AVCOOADP HEALTH LIMITEDNUH2025-09-18
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NUH2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.NUH2025-09-11
00810113683379DualPulse CompactManamed, Inc.NUH2025-09-11
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00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.NUH2025-08-21
00092237621974TwinStimDrive Devilbiss HealthcareNUH2025-08-15
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00850073128091AVCOOADP HEALTH LIMITEDNUH2025-05-26
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