FDA.reportPublic FDA data

Energy Flo J-Type Acupuncture Needles

Primary DI
B517100403010
Brand
Energy Flo J-Type Acupuncture Needles
Company
Acu Market
Model
CE-03 0.30 X 40MM WITH TUBE
Published
2023-06-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MQXNeedle, Acupuncture, Single Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQXNeedle, Acupuncture, Single UseGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002411000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002411000SHENLING ACUPUNCTURE NEEDLESShenling Medical Device Co., Ltd.2000-12-12MQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B517100403010PrimaryHIBCC0
B5171004030101Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Acupuncture needle, single-useA sterile, long, slender, sharply-pointed instrument used to stimulate peripheral nerves in order to produce surgical anaesthesia, relieve pain, and to promote other therapeutic effects. It is widely used in complementary therapy. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length40Millimeter
Outer Diameter0.3Millimeter

Regulatory Flags#

DUNS number
150890841
Device count
1000
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B5171004590Energy Flo Value-Pak J Type Acupuncture NeedlesCE-03V 0.14X15MM J-TYPE VALUE PAK2026-01-06
B5171005080Energy Flo Value-Pak J Type Acupuncture NeedlesCE-03V 0.30X75MM J-TYPE VALUE PAK2026-01-06
B5171005090Energy Flo Value-Pak J Type Acupuncture NeedlesCE-03V 0.25X40MM J-TYPE VALUE PAK2026-01-06
B5171005100Energy Flo Value-Pak J Type Acupuncture NeedlesCE-03V 0.14X30MM J-TYPE VALUE PAK2026-01-06
B5171005120Energy Flo Value-Pak J Type Acupuncture NeedlesCE-03V 0.25X50MM J-TYPE VALUE PAK2026-01-06
B51710045901Energy Flo Value-Pak J Type Acupuncture NeedlesCE-03V 0.14X15MM J-TYPE VALUE PAK2026-01-06
B51710050801Energy Flo Value-Pak J Type Acupuncture NeedlesCE-03V 0.30X75MM J-TYPE VALUE PAK2026-01-06
B51710050901Energy Flo Value-Pak J Type Acupuncture NeedlesCE-03V 0.25X40MM J-TYPE VALUE PAK2026-01-06
B51710051001Energy Flo Value-Pak J Type Acupuncture NeedlesCE-03V 0.14X30MM J-TYPE VALUE PAK2026-01-06
B51710051201Energy Flo Value-Pak J Type Acupuncture NeedlesCE-03V 0.25X50MM J-TYPE VALUE PAK2026-01-06
B5171003910Energy Flo J-Type Acupuncture NeedlesCE-03 0.25 X 75MM WITH TUBE2023-06-07
B517100391010Energy Flo J-Type Acupuncture NeedlesCE-03 0.25 X 75MM WITH TUBE2023-06-07
B5171003920Energy Flo J-Type Acupuncture NeedlesCE-03 0.30 X 75MM WITH TUBE2023-06-07
B517100392010Energy Flo J-Type Acupuncture NeedlesCE-03 0.30 X 75MM WITH TUBE2023-06-07
B5171004030Energy Flo J-Type Acupuncture NeedlesCE-03 0.30 X 40MM WITH TUBE2023-06-07
B5171004950Peace Classic Acupuncture NeedlesCES-08 (30) X 4 WITH TUBE2023-06-07
B5171005300Energy Flo J-Type Acupuncture NeedlesCE-03 0.12 X 15MM WITH TUBE2023-06-07
B517100530010Energy Flo J-Type Acupuncture NeedlesCE-03 0.12 X 15MM WITH TUBE2023-06-07
B5171005700Energy Flo J-Type Acupuncture NeedlesCE-03 0.14 X 15MM WITH TUBE2023-06-07
B517100570010Energy Flo J-Type Acupuncture NeedlesCE-03 0.14 X 15MM WITH TUBE2023-06-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08437016482285AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482292AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482308AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482315AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482322AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482339AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482407AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482414AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482421AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482438AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482445AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482452AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482469AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482476AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482483AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482490AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482506AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482513AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482520AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482537AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482551AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482568AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482575AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482582AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482599AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482605AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482612AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482629AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482636AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482643AGUPUNT APSAGU PUNT SLMQX2022-04-27