FDA.reportPublic FDA data

Tai Chi™ Power 80

Primary DI
16970514320097
Brand
Tai Chi™ Power 80
Company
Suzhou Shenlong Medical Apparatus Co., Ltd.
Model
AY7109
Catalog number
AY71019
Device description
"Painless Tai Chi™ needles, in economical bulk packaging. Made of surgical stainless steel, Tai Chi™ Power 80 needles provide practitioners with a high quality needle at an affordable price. The flexible ""spring"" style metal handle provides superior grip for the practitioner, while the advanced manufacturing process provides a painless experience for the patient. Each easy-open plastic package contains eight sterile acupuncture needles with one insertion tube. Box of 80 needles, 0.20 x 40 mm."
Published
2016-07-22
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

Contact Domains#

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
K023787000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023787000TAI-CHI AND MASTER ACUPUNCTURE NEEDLESLhasa Medical, Inc.2003-02-14MQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
36970514320091PackageGS110In Commercial Distribution
16970514320097PrimaryGS10
06970514320090Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3697051432009136970514320091
1697051432009716970514320097
06970514320090069705143200906970514320090

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
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
800-722-8775customerservice@lhasaoms.com

Regulatory Flags#

DUNS number
545745192
Device count
80
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14897076721778Roll.Smoke.LGY55102023-04-07
16970514320028Tai Chi™ Power 80AY7102AY710122016-07-22
16970514320035Tai Chi™ Power 80AY7103AY710132016-07-22
16970514320042Tai Chi™ Power 80AY7104AY710142016-07-22
16970514320059Tai Chi™ Power 80AY7105AY710152016-07-22
16970514320066Tai Chi™ Power 80AY7106AY710162016-07-22
16970514320073Tai Chi™ Power 80AY7107AY710172016-07-22
16970514320080Tai Chi™ Power 80AY7108AY710182016-07-22
16970514320103Tai Chi™ Power 80AY7110AY71102016-07-22
16970514320110Tai Chi™ Power 80AY7111AY71112016-07-22
16970514320127Tai Chi™ SingleAY8423AY84232016-07-22
16970514320134Tai Chi™ SingleAY8101AY81012016-07-22
16970514320141Tai Chi™ SingleAY8102AY81022016-07-22
16970514320158Tai Chi™ SingleAY8103AY81032016-07-22
16970514320165Tai Chi™ SingleAY8424AY84242016-07-22
16970514320172Tai Chi™ SingleAY8106AY81062016-07-22
16970514320189Tai Chi™ SingleAY8107AY81072016-07-22
16970514320196Tai Chi™ SingleAY8108AY81082016-07-22
16970514320202Tai Chi™ SingleAY8109AY81092016-07-22
16970514320219Tai Chi™ SingleAY8110AY81102016-07-26

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