Identity
- Trade Name
- Jiajian FDA UDI
- Generic Name
- Acupuncture point detector FDA UDI
- Device Name
- An electronic probe used to precisely locate an acupuncture point on a patient's body.It is used in complemently medicine therapy either independently or with a device intented to apply stilmuli to acupuncture site (e.g., an electrical stimulator). It may include visual or audio singals to indicate the acupuncture point. This is a reusable device. FDA UDI
- Model / Reference
- pointoselect FDA UDI
- Description
- An electronic probe used to precisely locate an acupuncture point on a patient's body.It is used in complemently medicine therapy either independently or with a device intented to apply stilmuli to acupuncture site (e.g., an electrical stimulator). It may include visual or audio singals to indicate the acupuncture point. This is a reusable device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815005021505 FDA UDI
- 510(k) Number
- K123958 FDA UDI
- FDA Product Code
- GZJ FDA UDI
- GMDN Term
- Acupuncture point detector FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5890 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Acupuncture point detector
Jiajian by Wuxi Jiajian Medical Instrument Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Acupuncture point detector.
- POINT MATE — TENS PLUS INDUSTRIAL COMPANY · Class II
- Tsun.Meter — TENS PLUS INDUSTRIAL COMPANY · Class II
- POINTER PAL — TENS PLUS INDUSTRIAL COMPANY · Class II
- Jiajian — Wuxi Jiajian Medical Instrument Co., Ltd. · Class II
- Jiajian — Wuxi Jiajian Medical Instrument Co., Ltd. · Class II
Cleared under the same submission
K123958 also covers:
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
- Wuxi Jiajian Medical Instrument Co., Ltd.
Sources (1)
- FDA UDI d4867640-bf9b-4231-9459-67f9f54b8db5 34 fields · synced May 31, 2026