Question 1

What does Somatics, LLC manufacture?

Accepted Answer

Somatics, LLC manufactures electrocardiographic electrodes, cardiac radio-frequency ablation system catheters, and related accessories such as remote treatment handles, monitoring cables, insulated handles, disposable recording electrodes, oral protectors for ECT, and lead wire sets for the Thymatron System IV.

The company's devices are classified as Class I and Class IIb and are listed in the Eudamed registry. Somatics, LLC is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Question 2

Where is Somatics, LLC based?

Accepted Answer

Somatics, LLC is based in the United States, as explicitly stated in the summary section of the device data, which confirms the company's country of origin without referencing any approval status or facility details.

Question 3

In which regulatory registry are Somatics, LLC's devices listed?

Accepted Answer

Somatics, LLC's devices are listed in the Eudamed registry, as directly indicated in the LISTED IN field and reiterated in the summary, which specifies the registry without implying any form of device authorization or company certification.

Question 4

How are Somatics, LLC's devices classified?

Accepted Answer

Somatics, LLC's devices are classified as Class I and Class IIb, according to the DEVICE CLASSES field in the data, which identifies the risk-based categories applicable to their products without suggesting that the company itself holds any classification status.

Device	Model / Reference	Registries	Class	Status
Remote Treatment Handle	ERTH	EUDAMED	Class I	Active
Mouth Protector (EMGS)	EMGS	EUDAMED	Class I	Active
Monitoring Cable, Gray System IV	ECEF-4	EUDAMED	Class I	Active
Steel Electrode, Cupped	EECU	EUDAMED	Class I	Active
Insulated Handle	EHAN	EUDAMED	Class I	Active
Stick on Snap On Disposable Recording Electrodes	EEDS	EUDAMED	Class I	Active
VENTIL-A Disposable Oral Protectors for ECT	VENTIL-A	EUDAMED	Class I	Active
EctoBrain II	ERTH	EUDAMED	Class I	Active
Disposable Eeg/Ekg Electrode, Cat. #eeds	K890710	FDA 510(k)	Class II	Active
Somatics Mouth Guard (bite Block)	K864181	FDA 510(k)	Class II	Active
Dual Graph (tm) Recorder-Monitor	K890711	FDA 510(k)	Class I	Active
Ventil-A Oral Protector	K992269	FDA 510(k)	Class II	Active
Thymatron 2000 Electroconvulsive System	K945120	FDA 510(k)	Class II	Active
Thymapad	K882809	FDA 510(k)	Class II	Active
Thymatron	K843923	FDA 510(k)	Class II	Active
Monitoring Lead Wires for Thymatron System IV 24" Leads Set of 5	ELDSC-5	EUDAMED	Class I	Active
Thymatron System IV	EDIV	EUDAMEDFDA UDI	Class IIb	Active
Monitoring Lead Wires for Thymatron System IV 24" Leads Set of 9	ELDSC-9	EUDAMED	Class I	Active
Disposable Oral Protectors for ECT	VENT	EUDAMED	Class I	Active
Foam Pressure Applicator Handle	EHAN-S	EUDAMED	Class I	Active
Stainless Steel Electrode FLAT BiLateral	EEFL	EUDAMED	Class I	Active
Monitoring Lead Wires for EMG Monitoring 60" Leads Set of 2	ELDS-BR	EUDAMED	Class I	Active
Thymapad	EPAD	EUDAMED	Class I	Active
ECT Treatment Cable	ECET-P	EUDAMED	Class I	Active

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