Cadwell Sierra Summit, Cadwell Sierra Ascent
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Cadwell Sierra Summit EUDAMEDSierra Summit FDA UDI
- Generic Name
- Electromyograph FDA UDI
- Device Name
- Ring or Bar Elect Switch Box, with DIN FDA UDIRING/BAR ELECTRODE SWITCH BOX FDA UDISUMMIT ER-3C INSERT EARPHONE CABLE FDA UDIVEP Cal Sensor FDA UDISierra Summit Remote Input Box FDA UDI
- Model / Reference
- 190317-200 EUDAMEDFDA UDI190292-200 EUDAMEDFDA UDI199295-200 EUDAMEDFDA UDI190283-200 EUDAMEDFDA UDI190285-200 EUDAMEDFDA UDINeuro Accessory EUDAMED
- Description
- Ring or Bar Elect Switch Box, with DIN FDA UDIRING/BAR ELECTRODE SWITCH BOX FDA UDISUMMIT ER-3C INSERT EARPHONE CABLE FDA UDIVEP Cal Sensor FDA UDISierra Summit Remote Input Box FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840067103982 EUDAMEDFDA UDI00840067100264 EUDAMEDFDA UDI00840067102848 EUDAMEDFDA UDI00840067100288 EUDAMEDFDA UDI00840067100301 EUDAMEDFDA UDI
- Basic UDI-DI
- 08400671NeuroAccClass13E EUDAMED08400671NeuroAccessoryQX EUDAMED
- 510(k) Number
- K162383 FDA 510(k)
- FDA Product Code
- IKN FDA 510(k)FDA UDIGWE FDA UDIJXE FDA UDIGWF FDA UDIGZP FDA UDIGWJ FDA UDIOLV FDA UDIGWQ FDA UDIOLT FDA UDI
- EMDN Code
- Z12100480 ELECTROMYOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMEDN010180 NEUROPHYSIOLOGY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Electromyograph FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 890.1375 FDA 510(k)
- Regulation Number
- 890.1375 FDA 510(k)FDA UDI882.1890 FDA UDI882.1550 FDA UDI882.1870 FDA UDI882.1880 FDA UDI882.1900 FDA UDI882.1400 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
The Cadwell Sierra Summit and Cadwell Sierra Ascent are diagnostic electromyographs, designed for assessing neuromuscular function. These devices record and analyze electrical activity produced by skeletal muscles and their motor neurons, aiding in the diagnosis of neuromuscular disorders, peripheral neuropathies, and other conditions affecting nerve and muscle function.
Used primarily in clinical settings such as physical medicine offices, hospitals, and specialized neuromuscular laboratories, these devices are supplied as reusable medical equipment. They are not intended for MRI environments and require proper calibration and maintenance. Authorized under FDA 510(k) clearance and MDR compliance, the devices are categorized under Class II medical devices, adhering to regulatory standards for diagnostic electromyography systems.
Frequently asked questions
What clinical environments are the Cadwell Sierra Summit and Cadwell Sierra Ascent primarily intended for use in?
The Cadwell Sierra Summit and Cadwell Sierra Ascent are designed for clinical settings such as physical medicine offices, hospitals, and specialized neuromuscular laboratories. These environments are ideal for assessing neuromuscular function through electromyography (EMG) due to their diagnostic capabilities and the need for structured evaluation of nerve and muscle disorders.
Are the Cadwell Sierra Summit and Cadwell Sierra Ascent reusable or single-use devices?
The Cadwell Sierra Summit and Cadwell Sierra Ascent are supplied as reusable medical equipment. This means they are intended for repeated use in clinical settings after proper cleaning, calibration, and maintenance to ensure accuracy and safety.
Can these devices be used in an MRI environment?
No, the Cadwell Sierra Summit and Cadwell Sierra Ascent are explicitly not intended for use in MRI environments. This is likely due to potential electromagnetic interference or safety concerns related to the strong magnetic fields used in MRI scans.
What regulatory pathways have the Cadwell Sierra Summit and Cadwell Sierra Ascent followed?
The devices have undergone FDA 510(k) clearance and comply with the EU Medical Device Regulation (MDR). They are classified as Class II medical devices, adhering to regulatory standards for diagnostic electromyography systems. The FDA clearance was granted under a traditional review process by the Physical Medicine Advisory Committee.
Do these devices require special handling or maintenance beyond standard cleaning?
Yes, the Cadwell Sierra Summit and Cadwell Sierra Ascent require proper calibration and maintenance to ensure accurate and reliable performance. Since they are reusable, adherence to manufacturer guidelines for cleaning, disinfection, and periodic calibration is essential to maintain diagnostic integrity and prevent equipment degradation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K162383 | Class II | Active |
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Manufacturer
- Manufacturer
- Cadwell Industries, Inc.
Sources (11)
- FDA 510(k) K162383 24 fields · synced Oct 6, 2026
- FDA UDI 8a125399-4978-4089-ba7d-22797fd486d5 34 fields · synced May 30, 2026
- FDA UDI c95aac23-2516-4753-bbd1-4e52f56a89ef 34 fields · synced May 30, 2026
- FDA UDI 3f3627d3-1790-4f1f-bc1f-f9de93d3eb76 34 fields · synced May 30, 2026
- FDA UDI a4dda780-7ba5-428e-9175-043ba366954e 34 fields · synced May 30, 2026
- FDA UDI 6432e10d-dd1d-446f-970b-77ea45fdf3aa 34 fields · synced May 30, 2026
- EUDAMED e9fbba71-8577-4768-81c8-57d8eaabf0bc 61 fields · synced Jul 9, 2026
- EUDAMED bff98184-2a0f-467a-a472-f102bddc117b 61 fields · synced Jul 12, 2026
- EUDAMED 5629ad4d-d120-4bfc-84db-6422288ce37b 61 fields · synced Jul 16, 2026
- EUDAMED bf2dc98d-bbda-427d-887e-14597879cc58 61 fields · synced Jul 19, 2026
- EUDAMED 9bc7b2b1-f506-4a4f-85ca-2b22cc573cd9 61 fields · synced Jul 27, 2026