Identity
- Trade Name
- Tempo J-Type Acupuncture Needle FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- Featuring a lightweight and ergonomic plastic handle, the J-type is designed for maximum comfort for both patient and acupuncturist. FDA UDI
- Model / Reference
- Tempo J-Type 2050 FDA UDI
- Description
- Featuring a lightweight and ergonomic plastic handle, the J-type is designed for maximum comfort for both patient and acupuncturist. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10854166000117 FDA UDI
- 510(k) Number
- K150903 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
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Length — 50 Millimeter FDA UDIOuter Diameter — 0.2 Millimeter FDA UDI
Category: Acupuncture needle, single-use
Tempo J-Type Acupuncture Needle by Blue Poppy Enterprises — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Acupuncture needle, single-use.
- Energy Flo Value-Pak J Type Acupuncture Needles — Acu Market · Class II
- ASIA MED — asia-med GmbH · Class II
- CARBO — WuJiang City Cloud&Dragon Medical Device Co., Ltd. · Class II
- STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE — Changchun AIK Medical Devices Co., Ltd. · Class II
- SHUNLI — Wuxi Jiajian Medical Instrument Co., Ltd. · Class II
- AcuZone — Wujiang City ShenLing Medical Device Co., Ltd · Class II
- ASIA MED — asia-med GmbH · Class II
- Millennia Bulk Acupuncture Needle — UPC MEDICAL SUPPLIES, INC. · Class II
Cleared under the same submission
K150903 also covers:
- Balance — BLUE POPPY ENTERPRISES
- Balance — BLUE POPPY ENTERPRISES
- Balance P-Type Acupuncture Needle — BLUE POPPY ENTERPRISES
- Balance P-Type Acupuncture Needle — BLUE POPPY ENTERPRISES
- Balance P-Type Acupuncture Needle — BLUE POPPY ENTERPRISES
- Balance SL-Type Acupuncture Needle — BLUE POPPY ENTERPRISES
- Balance SL-Type Acupuncture Needle — BLUE POPPY ENTERPRISES
- Balance SL-Type Acupuncture Needle — BLUE POPPY ENTERPRISES
- Balance SL-Type Acupuncture Needle — BLUE POPPY ENTERPRISES
- Tempo — BLUE POPPY ENTERPRISES
- Tempo — BLUE POPPY ENTERPRISES
- Tempo J-Type Acupuncture Needle — BLUE POPPY ENTERPRISES
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
- Blue Poppy Enterprises
Sources (1)
- FDA UDI 70e94155-1d12-4634-a166-d247b264bee2 35 fields · synced May 30, 2026