Identity
- Trade Name
- Balance 1KS Acupuncture Needle FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- Featuring a traditional “spring” style handle that comes in blister packs of 10 needles and one guide tube, the Balance 1KS is an achievement in combining the highest quality with unprecedented value. FDA UDI
- Model / Reference
- Balance 1KS-Type 2540 FDA UDI
- Description
- Featuring a traditional “spring” style handle that comes in blister packs of 10 needles and one guide tube, the Balance 1KS is an achievement in combining the highest quality with unprecedented value. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10854166000742 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 0.25 Millimeter FDA UDILength — 40 Millimeter FDA UDI
Category: Acupuncture needle, single-use
Balance 1KS 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Blue Poppy Enterprises
Sources (1)
- FDA UDI 7c8e0ae2-7408-4b1b-b8e4-b5c53eb5a0bc 35 fields · synced Jun 1, 2026