FDA.reportPublic FDA data

LEKON

Primary DI
00807689000907
Brand
LEKON
Company
C A I INDUSTRIES CORP
Model
NA-LK10-2507
Device description
acupuncture needles
Published
2025-12-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00807689003915PrimaryGS10
00807689003922PrimaryGS10
00807689003939PrimaryGS10
00807689003953PrimaryGS10
00807689003960PrimaryGS10
00807689003977PrimaryGS10
00807689004028PrimaryGS10
00807689004073PrimaryGS10
00807689004240PrimaryGS10
00807689000907Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00807689003915008076890039158076890039150807689003915
00807689003922008076890039228076890039220807689003922
00807689003939008076890039398076890039390807689003939
00807689003953008076890039538076890039530807689003953
00807689003960008076890039608076890039600807689003960
00807689003977008076890039778076890039770807689003977
00807689004028008076890040288076890040280807689004028
00807689004073008076890040738076890040730807689004073
00807689004240008076890042408076890042400807689004240
00807689000907008076890009078076890009070807689000907

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
1000
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
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
00807689003656LEKONNA-LK01-16152025-12-31
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

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