Identity
- Trade Name
- Sense System with IBT Electrodes FDA UDI
- Generic Name
- Myoelectric hand prosthesis FDA UDI
- Device Name
- Surface electrodes for Electromyography with Pattern Recognition controller - Hand and Wrist (with grips) - iLimb FDA UDI
- Model / Reference
- 70101-3-3 FDA UDI
- Description
- Surface electrodes for Electromyography with Pattern Recognition controller - Hand and Wrist (with grips) - iLimb FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850004850268 FDA UDI
- 510(k) Number
- K182112 FDA UDI
- FDA Product Code
- GXY FDA UDIIQZ FDA UDI
- GMDN Term
- Myoelectric hand prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 FDA UDI890.3420 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Analytical non-scalp cutaneous electrodeMyoelectric hand prosthesis
Sense System with IBT Electrodes by Infinite Biomedical Technologies LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Myoelectric hand prosthesis.
- Remote Electrode — Otto Bock Healthcare Products GmbH · Class II
- S-CHARGE — HUGH STEEPER LIMITED · Class I
- Luke Replaceable Part — MOBIUS BIONICS LLC · Class II
- Luke Replaceable Part — MOBIUS BIONICS LLC · Class II
- BATTERY SYSTEM — HUGH STEEPER LIMITED · Class I
- Luke Replaceable Part — MOBIUS BIONICS LLC · Class II
- Luke Replaceable Part — MOBIUS BIONICS LLC · Class II
- Remote Electrode — Otto Bock Healthcare Products GmbH · Class II
Cleared under the same submission
K182112 also covers:
- Sense System with IBT Electrodes — Infinite Biomedical Technologies LLC
- Sense System with IBT Electrodes — Infinite Biomedical Technologies LLC
- Sense System with IBT Electrodes — Infinite Biomedical Technologies LLC
- Sense System with IBT Electrodes — Infinite Biomedical Technologies LLC
- Sense System with IBT Electrodes — Infinite Biomedical Technologies LLC
- Sense System with IBT Electrodes — Infinite Biomedical Technologies LLC
- Sense System with IBT Electrodes — Infinite Biomedical Technologies LLC
- Sense System with IBT Electrodes — Infinite Biomedical Technologies LLC
- Sense System with IBT Electrodes — Infinite Biomedical Technologies LLC
- Sense System with IBT Electrodes — Infinite Biomedical Technologies LLC
- Sense System with IBT Electrodes — Infinite Biomedical Technologies LLC
- Sense System with IBT Electrodes — Infinite Biomedical Technologies LLC
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
- Infinite Biomedical Technologies LLC
Sources (1)
- FDA UDI f548d46e-0061-41c6-86e8-35256b85ee8d 35 fields · synced May 30, 2026