Identity
- Trade Name
- Solo Pace Control System FDA UDI
- Generic Name
- External pacemaker, epicardial pacing FDA UDI
- Device Name
- Solo Pace Control External Pulse Generator FDA UDI
- Model / Reference
- SOLOEPG1L FDA UDI
- Description
- Solo Pace Control External Pulse Generator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850056280037 FDA UDI
- 510(k) Number
- K241781 FDA UDI
- FDA Product Code
- DTE FDA UDI
- GMDN Term
- External pacemaker, epicardial pacing FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3600 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: External pacemaker, epicardial pacing
Solo Pace Control System by Solo Pace Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External pacemaker, epicardial pacing.
- CARDIOTRONIC — Osypka Medical, Inc. · Class II
- STREAMLINE™ — MEDTRONIC, INC. · Class II
- Bloom — Fischer Medical · Class II
- STREAMLINE™ — MEDTRONIC, INC. · Class II
- Osypka Medical — Osypka Medical, Inc. · Class II
- PACE 203H — Oscor Inc. · Class II
- STREAMLINE™ — MEDTRONIC, INC. · Class II
- CARDIOTRONIC — Osypka Medical, Inc. · Class II
Cleared under the same submission
K241781 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
- Solo Pace Inc
Sources (1)
- FDA UDI 31b2f232-bfac-478d-8b79-a84f55a29a46 34 fields · synced May 30, 2026