FDA.reportPublic FDA data

Tai Chi™ Five

Primary DI
36970514320367
Brand
Tai Chi™ Five
Company
Suzhou Shenlong Medical Apparatus Co., Ltd.
Model
AY8428
Catalog number
AY8428
Device description
Sterile, disposable, surgical stainless steel Chinese style acupuncture needles with spiral wound silver plated copper handle. Bulk package of 5 needl
Published
2016-07-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
36970514320367PackageGS110In Commercial Distribution
16970514320363PrimaryGS10
06970514320366Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3697051432036736970514320367
1697051432036316970514320363
06970514320366069705143203666970514320366

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
545745192
Device count
100
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
false
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
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
16970514320097Tai Chi™ Power 80AY7109AY710192016-07-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810202812642TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812666TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812680TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812703TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812727TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812741TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812765TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812789TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812802TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812826TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812840TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812864TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812888TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812901TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812925TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812956TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812970TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812994TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813014TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813038TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813052TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813076TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813090TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813113TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813137TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813151TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813175TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813199TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813212TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813236TCMzone HuaTuoTCMZone, LLCMQX2026-08-01