FDA.reportPublic FDA data

LEKON

Primary DI
00807689003656
Brand
LEKON
Company
C A I INDUSTRIES CORP
Model
NA-LK01-1615
Device description
Acupuncture needles
Published
2025-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00807689003656PrimaryGS10
00807689101512Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00807689003656008076890036568076890036560807689003656
00807689101512008076891015128076891015120807689101512

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
859060303
Device count
100
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00807689003618LEKONNA-LK01-12152025-12-31
00807689003625LEKONNA-LK01-12302025-12-31
00807689003632LEKONNA-LK01-14152025-12-31
00807689003915LEKONNA-LK01-12072025-12-31
00807689003922LEKONNA-LK01-14072025-12-31
00807689003939LEKONNA-LK01-16072025-12-31
00807689003953LEKONNA-LK01-20072025-12-31
00807689003960LEKONNA-LK01-22072025-12-31
00807689003977LEKONNA-LK01-25072025-12-31
00807689101512LEKONNA-LK01-14152025-12-31
00807689003649LEKONNA-LK01-14302025-12-31
00807689003663LEKONNA-LK01-16302025-12-31
00807689003670LEKONNA-LK01-16402025-12-31
00807689003687LEKONNA-LK01-18152025-12-31
00807689003694LEKONNA-LK01-18302025-12-31
00807689003700LEKONNA-LK01-18402025-12-31
00807689003717LEKONNA-LK01-20152025-12-31
00807689003724LEKONNA-LK01-20302025-12-31
00807689003731LEKONNA-LK01-20402025-12-31
00807689003748LEKONNA-LK01-20502025-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B5171004580Energy Flo J-Type Acupuncture NeedlesAcu MarketMQX2026-06-26
B517100458010Energy Flo J-Type Acupuncture NeedlesAcu MarketMQX2026-06-26
00816073022487SILVERSTARHealth Body World Supply Inc.MQX2026-06-23
00816073023347HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023354HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023361HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023378HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023385HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023392HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023408HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023415HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023422HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023576SILVERSTARHealth Body World Supply Inc.MQX2026-06-23
00816073023583SILVERSTARHealth Body World Supply Inc.MQX2026-06-23
00816073023644HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023651HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023675HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023682HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023699HyChi - Mini 5Health Body World Supply Inc.MQX2026-06-23
00816073023705HyChi - Mini 5Health Body World Supply Inc.MQX2026-06-23
00816073023712HyChi - Mini 5Health Body World Supply Inc.MQX2026-06-23
00816073023729HyChi - Mini 5Health Body World Supply Inc.MQX2026-06-23
00816073023736HyChi - Mini 5Health Body World Supply Inc.MQX2026-06-23
00816073023743HyChi - Mini 5Health Body World Supply Inc.MQX2026-06-23
00816073023750HyChi - Mini 5Health Body World Supply Inc.MQX2026-06-23
00816073023767HyChi - Mini 5Health Body World Supply Inc.MQX2026-06-23
00816073024221SILVERSTARHealth Body World Supply Inc.MQX2026-06-23
00816073024344SILVERSTARHealth Body World Supply Inc.MQX2026-06-23
00816073024351SILVERSTARHealth Body World Supply Inc.MQX2026-06-23
00816073024481SILVERSTARHealth Body World Supply Inc.MQX2026-06-23