Identity
- Trade Name
- AXUS ES-5 FDA UDI
- Generic Name
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
- Device Name
- The AXUS ES-5 is an electro-acupuncture device indicated for use in the practice of acupuncture by qualified professionals of acupuncture as determined by the state. The AXUS ES-5 is a battery operated prescription use only electro-acupuncture device used for applying electric stimuli to areas of preferred delivery (APD). The device uses a low-intensity, low-frequency pulse multimode generator through micro-alligator clips attached to commercially available and FDA-cleared stainless steel acupuncture needles. The device can also deliver stimulation with the included probe. FDA UDI
- Model / Reference
- ED3930 FDA UDI
- Description
- The AXUS ES-5 is an electro-acupuncture device indicated for use in the practice of acupuncture by qualified professionals of acupuncture as determined by the state. The AXUS ES-5 is a battery operated prescription use only electro-acupuncture device used for applying electric stimuli to areas of preferred delivery (APD). The device uses a low-intensity, low-frequency pulse multimode generator through micro-alligator clips attached to commercially available and FDA-cleared stainless steel acupuncture needles. The device can also deliver stimulation with the included probe. FDA UDI
Identifiers
- Catalog Number
- ED3930 FDA UDI
- Primary DI / UDI-DI
- 14897076720092 FDA UDI
- 510(k) Number
- K200636 FDA UDI
- FDA Product Code
- BWK FDA UDI
- GMDN Term
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Classification
- Device Class
- U 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Analgesic transcutaneous electrical nerve stimulation system
Axus Es-5 by Tens Plus Industrial Company — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Analgesic transcutaneous electrical nerve stimulation system.
- AVCOO — ADP HEALTH LIMITED · Class II
- AUVON — Shenzhen Yuwen E-Commerce Co., Ltd. · Class II
- HTG Life — FRAMEWERK LLC · Class II
- AUVON — Shenzhen Yuwen E-Commerce Co., Ltd. · Class II
- 1byone — 1BYONEPRODUCTS INC. · Class II
- AUVON — Shenzhen Yuwen E-Commerce Co., Ltd. · Class II
- Famidoc — FAMIDOC USA, INC. · Class II
- COMPEX — DJO, LLC · Class II
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 U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tens Plus Industrial Company
Sources (1)
- FDA UDI 6c53cf5a-700d-4d1e-a4b0-096d8d8d5da2 36 fields · synced May 30, 2026