Identity
- Trade Name
- Complete Calibrate FDA UDI
- Generic Name
- Myoelectric hand prosthesis FDA UDI
- Device Name
- Socket-Mount Calibration Unit FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Socket-Mount Calibration Unit FDA UDI
Identifiers
- Primary DI / UDI-DI
- B618D0 FDA UDI
- 510(k) Number
- K162891 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Myoelectric hand prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Myoelectric hand prosthesis
Complete Calibrate by Coapt, 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
- Sense System with IBT Electrodes — Infinite Biomedical Technologies LLC · 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
- Sense System with IBT Electrodes — Infinite Biomedical Technologies LLC · Class II
- BATTERY SYSTEM — HUGH STEEPER LIMITED · Class I
- Sense System with IBT Electrodes — Infinite Biomedical Technologies LLC · Class II
Cleared under the same submission
K162891 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 |
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Manufacturer
- Manufacturer
- Coapt, LLC
Sources (1)
- FDA UDI fcf19fa8-dff1-4516-9ef5-ff818e1d5003 34 fields · synced May 30, 2026