Identity
- Trade Name
- ENLIGHT BELT - 5S - LEFT FDA UDI
- Generic Name
- Thoracic electrical impedance electrode array, reusable FDA UDI
- Device Name
- The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex-free accessory in different sizes for adult and pediatric patients, designed for exclusive use with ENLIGHT. Non-sterile and not to be sterilized. It must be used with Addere. FDA UDI
- Model / Reference
- ACE-0001T-0 FDA UDI
- Description
- The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex-free accessory in different sizes for adult and pediatric patients, designed for exclusive use with ENLIGHT. Non-sterile and not to be sterilized. It must be used with Addere. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07898959841002 FDA UDI
- 510(k) Number
- K211135 FDA UDI
- FDA Product Code
- QEB FDA UDI
- GMDN Term
- Thoracic electrical impedance electrode array, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1505 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Thoracic electrical impedance electrode array, reusable
Enlight Belt - 5s - Left by Timpel S/A — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thoracic electrical impedance electrode array, reusable.
- ENLIGHT BELT - XS - RIGHT — Timpel S/A · Class II
- ENLIGHT BELT - 4S - LEFT — Timpel S/A · Class II
- ENLIGHT BELT - 5S - RIGHT — Timpel S/A · Class II
- ENLIGHT BELT - XXS - RIGHT — Timpel S/A · Class II
- ENLIGHT BELT - S - RIGHT — Timpel S/A · Class II
- ENLIGHT BELT - XL - RIGHT — Timpel S/A · Class II
- ENLIGHT BELT - M - RIGHT — Timpel S/A · Class II
- ENLIGHT BELT - M - LEFT — Timpel S/A · Class II
Cleared under the same submission
K211135 also covers:
- ENLIGHT 2100 — Timpel S/A
- ENLIGHT ADDERE - 4S — Timpel S/A
- ENLIGHT ADDERE - 5S — Timpel S/A
- ENLIGHT ADDERE - P0 — Timpel S/A
- ENLIGHT ADDERE - P1 — Timpel S/A
- ENLIGHT ADDERE - P2 — Timpel S/A
- ENLIGHT ADDERE - XL — Timpel S/A
- ENLIGHT ADDERE - XXS — Timpel S/A
- ENLIGHT BELT - 4S - LEFT — Timpel S/A
- ENLIGHT BELT - 4S - RIGHT — Timpel S/A
- ENLIGHT BELT - 5S - RIGHT — Timpel S/A
- ENLIGHT BELT - L - LEFT — Timpel S/A
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
- Timpel S/A
Sources (1)
- FDA UDI 3067a47b-3680-43c9-8144-009caa771e6d 34 fields · synced May 31, 2026