FDA.reportPublic FDA data

SPECTRAMED, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
15287641000136007SPECTRAMED, LLC1N2026-01-01275 W Johnstown Rd Gahanna OH US 43230

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
B73643211Guardian Unity - 2-channel neuromuscular stimulation device. Handheld, Portable and battery powered by 4 AA Alkaline batteries. Maximum device output 90mA with 7 pre-set programs1-800-643-1917info@spectramedonline.com
B736465731SwallowStim Classic - 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 program1-800-643-1917info@spectramedonline.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
465642027211004K120922GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNITIPF2013-02-07
465641299021659K023036CARE ETSIPF2003-06-19
465641328627313K020637SELECT STIMIPF2002-05-28

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IPF32013-02-07

PMN#

GUDID#