FDA.reportPublic FDA data

Energy Flo Value-Pak J Type Acupuncture Needles

Primary DI
B51710045901
Brand
Energy Flo Value-Pak J Type Acupuncture Needles
Company
Acu Market
Model
CE-03V 0.14X15MM J-TYPE VALUE PAK
Published
2026-01-06
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

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
B5171004590PrimaryHIBCC0
B51710045901Unit 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
Length15Millimeter
Outer Diameter0.14Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
150890841
Device count
500
DM exempt
false
Premarket exempt
false
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
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
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
B517100403010Energy 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
00816073022500HBW PINEHealth Body World Supply Inc.MQX2020-10-19
00816073022630HBW UNISHARPHealth Body World Supply Inc.MQX2019-07-12
00816073020797HBW SILVERSTARHealth Body World Supply Inc.MQX2019-06-26
00816073022616HBW PINEHealth Body World Supply Inc.MQX2019-04-15
00816073022470HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022524HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022531HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022548HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022555HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022562HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022579HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022586HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022609HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022395SILVERSTARHealth Body World Supply Inc.MQX2018-04-14
00816073022401SILVERSTARHealth Body World Supply Inc.MQX2018-04-14
00816073022166HBW HI.CHIHealth Body World Supply Inc.MQX2017-08-06
00816073022319HBW SILVERSTARHealth Body World Supply Inc.MQX2017-08-06
00816073022326HBW HI.CHIHealth Body World Supply Inc.MQX2017-08-06
00816073022333HBW SILVERSTARHealth Body World Supply Inc.MQX2017-08-06
00816073022340HBW SILVERSTARHealth Body World Supply Inc.MQX2017-08-06
00816073022036HBW PRESS NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022050HBW 7 STAR NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022067HBW 7 STAR NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022074HBW 7 STAR NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022098HBW DETOX NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022296HBW INTRADERMAL NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022302HBW INTRADERMAL NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022043HBW PRESS NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073021244HBW E FIVEHealth Body World Supply Inc.MQX2016-09-10
00816073021251HBW E FIVEHealth Body World Supply Inc.MQX2016-09-10