SPECTRAMED, INC.

SPECTRAMED, INC.

Address:275 W Johnstown Rd,Gahanna,OH,43230,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Stimulator, Muscle, Powered (IPF) (2)

Premarket Exempt

No

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Guardian Unity - B73643211 Catalog Number : 01GS90

Device Description : 2-channel neuromuscular stimulation device. Handheld, Portable and battery power 2-channel neuromuscular stimulation device. Handheld, Portable and battery powered by 4 AA Alkaline batteries. Maximum device output 90mA with 7 pre-set programs

Device Class : 2

Duns Number: 793161472

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

SwallowStim Classic - B736465731 Catalog Number : 01GS25

Device Description : 2-channel neuromuscular stimulation device. Handheld, Portable and battery power 2-channel neuromuscular stimulation device. Handheld, Portable and battery powered by 4 AA Alkaline batteries. Maximum device output 50mA peak to peak with 1 pre-set program

Device Class : 2

Duns Number: 793161472

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

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