Question 1

What types of medical devices does Spectramed, Inc. primarily manufacture?

Accepted Answer

Spectramed, Inc. specializes in Class II medical devices, including transcutaneous neuromuscular electrical stimulation systems for physical therapy, such as the SwallowStim Classic for swallowing rehabilitation. Additionally, the company produces medical accessories like blood sampling reservoirs, balance saver devices, and various transducers and catheters, including dual-lumen tipped catheters and percutaneous sheaths for intrauterine and intravascular use.

Question 2

Where is Spectramed, Inc. based, and where are its devices listed?

Accepted Answer

Spectramed, Inc. is based in the United States. Its devices are listed in the FDA’s 510(k) and Unique Device Identification (UDI) registries, reflecting their regulatory classification and compliance requirements under U.S. medical device regulations.

Question 3

How are Spectramed, Inc.’s devices classified under FDA regulations?

Accepted Answer

Spectramed, Inc.’s devices fall under Class II classification, which means they pose moderate risk and require premarket notification (510(k)) clearance before being marketed in the U.S. This classification ensures they meet specific performance standards and safety requirements before use.

Question 4

What kinds of devices does Spectramed, Inc. produce that are used in physical therapy?

Accepted Answer

Spectramed, Inc. manufactures transcutaneous neuromuscular electrical stimulation systems, such as the SwallowStim Classic, which are designed to aid in physical therapy for conditions like swallowing disorders. These devices deliver targeted electrical stimulation to promote muscle activation and rehabilitation.

Question 5

Are Spectramed, Inc.’s devices used in critical care or procedural settings?

Accepted Answer

Yes, Spectramed, Inc. produces devices like blood sampling reservoirs (e.g., SAFE-DRAW™) and transducers (e.g., DT-IUPC2 catheters) that are used in critical care and procedural settings. These accessories support intravascular and intrauterine monitoring or access, ensuring compatibility with medical procedures requiring precise fluid management or diagnostic sampling.

Device	Model / Reference	Registries	Class	Status
SwallowStim Classic	01GS25	FDA UDI	Class II	Active
Guardian Unity	01GS90	FDA UDI	Class II	Active
Spectramed Model Sp1455 Hemopro2 System	K865101	FDA 510(k)	Class II	Active
V-Pace(tm) Transluminal Ventricular/ Model Sp5540	K864507	FDA 510(k)	Class II	Active
Cco System Model Sp1467, Sp5567, Sp6267	K892941	FDA 510(k)	Class II	Active
Safe-Draw(tm) Blood Sampling Reservoir & Access.	K885235	FDA 510(k)	Class II	Active
Model Dt-Bal, Balance Saver	K895323	FDA 510(k)	Class II	Active
Models Sp5825/Sp5835/Sp5845/Sp5855 Percu. Sheath	K881825	FDA 510(k)	Class II	Active
Spectramed Disposable Transducer (dt-Xxo) & Access	K873168	FDA 510(k)	Class II	Active
Amnicathdl(tm) Dt-Iupc2 Dual Lumen Trans. Tipped	K896122	FDA 510(k)	Class II	Active
Amnicath(tm) Model Dt-Iupc Trans. Tipped Intrau.	K881857	FDA 510(k)	Class II	Active
Model Dt-Iupc2 Transducer Tipped Dual Lumen Iup	K894362	FDA 510(k)	Class II	Active
Central Venous Multi-Lumen Catheters And Kits	K871573	FDA 510(k)	Class II	Active
Model Ta-Cs10 Spectraject Control Syringe	K880740	FDA 510(k)	Class II	Active
Heparin Coated Luminal Pacing Catheter	K875337	FDA 510(k)	Class II	Active

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