Identity
- Trade Name
- Tai Chi™ Power 80 FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- 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, 0.18 x 15 mm. FDA UDI
- Model / Reference
- AY7102 FDA UDI
- 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, 0.18 x 15 mm. FDA UDI
Identifiers
- Catalog Number
- AY71012 FDA UDI
- Primary DI / UDI-DI
- 16970514320028 FDA UDI
- 510(k) Number
- K023787 FDA UDI
- FDA Product Code
- MQX FDA UDI
- GMDN Term
- Acupuncture needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5580 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Acupuncture needle, single-use
Tai Chi™ Power 80 by Suzhou Shenlong Medical Apparatus Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Acupuncture needle, single-use.
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Cleared under the same submission
K023787 also covers:
- Gold Tai Chi™ — Suzhou Shenlong Medical Apparatus Co., Ltd.
- Gold Tai Chi™ — Suzhou Shenlong Medical Apparatus Co., Ltd.
- Gold Tai Chi™ — Suzhou Shenlong Medical Apparatus Co., Ltd.
- Gold Tai Chi™ — Suzhou Shenlong Medical Apparatus Co., Ltd.
- Gold Tai Chi™ — Suzhou Shenlong Medical Apparatus Co., Ltd.
- Gold Tai Chi™ — Suzhou Shenlong Medical Apparatus Co., Ltd.
- Gold Tai Chi™ — Suzhou Shenlong Medical Apparatus Co., Ltd.
- Gold Tai Chi™ — Suzhou Shenlong Medical Apparatus Co., Ltd.
- Gold Tai Chi™ — Suzhou Shenlong Medical Apparatus Co., Ltd.
- Gold Tai Chi™ — Suzhou Shenlong Medical Apparatus Co., Ltd.
- Master Tai Chi™ — Suzhou Shenlong Medical Apparatus Co., Ltd.
- Master Tai Chi™ — Suzhou Shenlong Medical Apparatus Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Suzhou Shenlong Medical Apparatus Co., Ltd.
Sources (1)
- FDA UDI b1e64da1-7de1-476b-b3ff-b3367adb0df6 37 fields · synced May 29, 2026