FDA.reportPublic FDA data

Tempo J-Type Acupuncture Needle

Primary DI
10854166000063
Brand
Tempo J-Type Acupuncture Needle
Company
BLUE POPPY ENTERPRISES INC.
Model
Tempo J-Type 1640
Device description
Featuring a lightweight and ergonomic plastic handle, the J-type is designed for maximum comfort for both patient and acupuncturist.
Published
2019-01-11
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150903000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150903000EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral NaturalMaanshan Bond Medical Instruments Co., Ltd.2015-07-15MQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10854166000063PrimaryGS10
30854166000067Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085416600006310854166000063
3085416600006730854166000067

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 Diameter0.16Millimeter

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
080493003
Device count
100
Lot or batch
true
Serial number
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10854166000230Tempo L-Type Acupuncture NeedleTempo L-Type 16302019-01-14
10854166000001Tempo J-Type Acupuncture NeedleTempo J-Type 12152019-01-11
10854166000049Tempo J-Type Acupuncture NeedleTempo J-Type 16152019-01-11
10854166000056Tempo J-Type Acupuncture NeedleTempo J-Type 16302019-01-11
10854166000087Tempo J-Type Acupuncture NeedleTempo J-Type 18402019-01-11
10854166000100Tempo J-Type Acupuncture NeedleTempo J-Type 20402019-01-11
10854166000117Tempo J-Type Acupuncture NeedleTempo J-Type 20502019-01-11
10854166000124Tempo J-Type Acupuncture NeedleTempo J-Type 22302019-01-11
10854166000131Tempo J-Type Acupuncture NeedleTempo J-Type 22402019-01-11
10854166000148Tempo J-Type Acupuncture NeedleTempo J-Type 25302019-01-11
10854166000155Tempo J-Type Acupuncture NeedleTempo J-Type 25402019-01-11
10854166000179Tempo J-Type Acupuncture NeedleTempo J-Type 30302019-01-11
10854166000186Tempo J-Type Acupuncture NeedleTempo J-Type 30402019-01-11
10854166000193Tempo J-Type Acupuncture NeedleTempo J-Type 30502019-01-11
10854166000209Tempo J-Type Acupuncture NeedleTempo J-Type 30602019-01-11
10854166000247Tempo L-Type Acupuncture NeedleTempo L-Type 18302019-01-11
10854166000254Tempo L-Type Acupuncture NeedleTempo L-Type 18402019-01-11
10854166000278Tempo L-Type Acupuncture NeedleTempo L-Type 20402019-01-11
10854166000308Tempo L-Type Acupuncture NeedleTempo L-Type 22402019-01-11
10854166000315Tempo L-Type Acupuncture NeedleTempo L-Type 25302019-01-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00807689000365LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000372LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000389LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000396LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000402LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000419LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000426LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000433LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000440LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000457LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000464LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000471LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000488LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000495LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000501LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000518LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000525LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000532LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000549LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000556LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000563LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000570LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000587LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000594LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000600LEKONC A I INDUSTRIES CORPMQX2026-07-11
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