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Data / Medical devices / System, Communication, Powered

System, Communication, Powered (ILQ): 42 FDA-registered makers in 10 countries

42 establishments in 10 countries are registered with the FDA to make System, Communication, Powered (product code ILQ, Class 2, 21 CFR 890.3710). 0 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 38 510(k) clearances under this code, the latest on January 18, 2017, and lists 16 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
ILQ
Device class
2
Regulation
890.3710
Medical specialty
Physical Medicine

Makers by country

CountryMakers
United States31
Taiwan3
Sweden1
Israel1
Norway1
Germany1
Spain1
Belgium1
United Kingdom1
China1

Makers of System, Communication, Powered

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Ablenet, Inc.Roseville, MN, United StatesManufacturer0000api.fda.gov
Aionex, Inc.Madison, TN, United StatesManufacturer0000api.fda.gov
Anacom General CorporationAnaheim, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Austco Marketing & Service (usa) Ltd.Irving, TX, United StatesManufacturer0000api.fda.gov
Befitting You, LLCCommerce Twp, MI, United StatesSpecification developer0000api.fda.gov
Cadwell Industries, Inc.Kennewick, WA, United StatesSpecification developer0000api.fda.gov
Control Bionics Inc.Milford, OH, United StatesManufacturer, Specification developer0000api.fda.gov
Crest Electronics Inc.Dassel, MN, United StatesManufacturer0000api.fda.gov
Curbell Medical Products, Inc.Orchard Park, NY, United StatesManufacturer, Specification developer0000api.fda.gov
DYNAVOX Group ABStockholm, SwedenComplaint file establishment, Specification developer0000api.fda.gov
Eyefree Assisting Communication LtdTel Aviv, IsraelManufacturer0000api.fda.gov
Eyegaze Inc.Fairfax, VA, United StatesManufacturer0000api.fda.gov
Eyetech Digital SystemsTempe, AZ, United StatesSpecification developer0000api.fda.gov
Forbes Rehab Services Inc.Mansfield, OH, United StatesManufacturer0010api.fda.gov
Grasp ASOS Hordaland, NorwayComplaint file establishment, Specification developer0000api.fda.gov
Hasomed GMBHMagdeburg Saxony-Anhalt, GermanyManufacturer0000api.fda.gov
Hatchmed CorporationKent, WA, United StatesManufacturer0000api.fda.gov
Hill-Rom, Inc.Raleigh, NC, United StatesComplaint file establishment, Manufacturer0010api.fda.gov
Intego Software, LLC D/B/A Critical AlertJacksonville, FL, United StatesManufacturer, Specification developer0000api.fda.gov
Irisbond Crowdbonding, S.L.Donostia San Sebastian Guipuzcoa, SpainManufacturer0000api.fda.gov
JabblaGent Oost-Vlaanderen, BelgiumManufacturer0000api.fda.gov
Jeron Electronic Systems IncNiles, IL, United StatesManufacturer0000api.fda.gov
KESTRA Medical Technologies, Inc.Kirkland, WA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Lingraphicare America, Inc.Princeton, NJ, United StatesManufacturer0000api.fda.gov
Med Labs, Inc.Goleta, CA, United StatesManufacturer0000api.fda.gov
MedMinder Systems, Inc.Norwood, MA, United StatesComplaint file establishment, Manufacturer0010api.fda.gov
New V-Key Technology Co., Ltd.New Taipei City, Taipei, TaiwanContract manufacturer, Exporter to the US, Specification developer0000api.fda.gov
Onyx Healthcare Inc.New Taipei City, TaiwanManufacturer0000api.fda.gov
Onyx Healthcare Usa, Inc.Orange, CA, United StatesManufacturer0000api.fda.gov
Prentke Romich CompanyWooster, OH, United StatesManufacturer0000api.fda.gov
Proxtalker.com LLCWaterbury, CT, United StatesManufacturer0000api.fda.gov
R & D Batteries, Inc.Burnsville, MN, United StatesManufacturer0000api.fda.gov
RCS Management CorporationSurprise, AZ, United StatesManufacturer0000api.fda.gov
Reliance Mobility LLCColumbia, TN, United StatesManufacturer0000api.fda.gov
S-Comm, Inc.Raytown, MO, United StatesSpecification developer0000api.fda.gov
Shelton Technologies And Resources LLCLakeland, FL, United StatesManufacturer0000api.fda.gov
Smartbox Assistive Technology IncLower Burrell, PA, United StatesManufacturer0000api.fda.gov
Smartbox Assistive Technology LtdMalvern Worcestershire, United KingdomManufacturer0000api.fda.gov
Smartbox UsCedar Falls, IA, United StatesManufacturer0000api.fda.gov
Shenzhen Contin Medical Device Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Taiwan Serpro CorporationTaipei City, TaiwanContract manufacturer0000api.fda.gov
Tobii Dynavox LLCCoraopolis, PA, United StatesComplaint file establishment, Manufacturer, Specification developer0030api.fda.gov

Updated January 18, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.