FDA.reportPublic FDA data

ABLE

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30015761733001576173ABLENET, INC.1N2026-01-012625 PATTON RD Roseville MN US 55113
30077985343007798534ABLEXAN CORPORATION1N2026-01-017424 Chapel Hill Road 204 Raleigh NC US 27607
30146807953014680795ABLE MEDICAL DEVICES1Y2026-01-01512 Fourth Street Gwinn MI US 49841
30208799413020879941ABLE SOLUTIONS. INC1N2026-01-01801 Friendship Dr Harrisonburg VA US 22802
30387765933038776593Able Medical Devices1N2026-01-012812 Beecher Street Marquette MI US 49855
30027714363002771436ABLE INDUSTRIAL PRODUCTS, INC1N2020-04-252006 S Baker Ave Ontario CA US 91761
30141282793014128279ABLE DIAGNOSTICS, INC.1Y2020-04-2512396 World Trade Drive, Suite 216, San Diego, CA 92128, San Diego CA US 92128
30152175803015217580ABLELINK ELECTRONICS LTD.1N2020-04-25182 Qingzhang Road, Chang Shan Tou, Qingxi Town Dongguan Guangdong CN 523661

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2206371726125353K232515Valkyrie Thoracic Fixation SystemHRS2023-12-08
3408531726125353K232515Valkyrie Thoracic Fixation SystemHRS2023-12-08
2206371870802596K211695Valkyrie Thoracic Fixation SystemHRS2021-06-23
3408531870802596K211695Valkyrie Thoracic Fixation SystemHRS2021-06-23
2206371800776941K202889Able Medical Devices Valkyrie Thoracic Fixation SystemHRS2021-03-02
3408531800776941K202889Able Medical Devices Valkyrie Thoracic Fixation SystemHRS2021-03-02
2206372018680884K190359Sonendo GentleWave SystemELC2019-03-16
1054661184012800K063442ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOREZL2007-03-26
2206371019090862
2206371074565695
2274301249050052
2206371516840088
2274301747234873
2206371847448021
2206371867368448
2054571921836673
2206371993670644
2206372008975153
2206371016516723
2206371022426066
2206371022572950
2206371034129829
3255781039916823
2206371043923819
2206371047958442
2206371051236728
2206371051289306
2206371082553621
2206371097618791
2206371106760380
2206371124180731
2206371126154360
3408531126154360
2206371136759219
2206371148879939
2206371153618817
2206371192517379
2206371192746205
2206371211436159
2206371262931117
2206371264907549
2206371280345466
2206371291481545
2206371292537513
2206371294297005
1054661300477229
1687081330976346
2206371361182701
2206371375277403
3255781397280003
2206371401456523
3408531401456523
2206371453306038
2206371457303873
2206371473354440
2206371474817999
2206371482389552
2206371483223512
3408531483223512
2206371507497716
2206371508069652
2206371529301277
2206371539169044
2206371541415050
2206371550950402
2206371551780858
2206371563401746
2206371568887320
2206371569864284
2206371594149821
2206371600876084
2206371605633899
2206371608699845
2206371629063364
2206371633538652
2206371639049470
3408531639049470
2206371661803301
2206371670608846
2206371674599564
3408531674599564
2206371681006193
2206371688891982
2206371698107231
2206371710152702
2206371710559189
2206371717306325
1687081717549084
2206371734177656
2206371779443492
2206371782534451
2206371797832235
2206371806163729
3408531806163729
2206371814547946
2206371823245785
2206371836605277
3408531847448021
2206371850335111
2206371870824470
2206371887209588
2206371890926476
2206371903505841
2206371913188035
2206371930089071
2206371930931045
2206371953351145
2206371963213437
2206371977612277
2206371978227207
2206371994779852
3408532008975153
2206372013342200
2206372020580377
2206372022303763
2206372026572540
2206372034973845
2206372054003441

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS62023-12-08
ELC12019-03-16
EZL12007-03-26

NDC#

PMN#

Applications#

62 records. Showing 1-40. Next

GUDID#

SuperTalker FeatherTouch - "The SuperTalker FeatherTouch speech device provides an opportunity for users of all abilities to communicate. Change out the message grids to create a unique speech device with one, two, four, or eight messages. The FeatherTouch membrane responds to the lightest touches and smallest fingers, and makes it easy for almost anyone to communicate with one message or eight different messages. Includes ableCARE on-demand support Built ableSTRONG to endure drops and other environmental conditions Made from ableSAFE materials and tested by third-party safety labsCommon Uses Record messages like ""turn the page"", ""look"", ""I like this"", and ""I want to stop"" for use when reading a book Record a single message to make a request like ""I want"" or ""I need help"" Add communication to a switch controlled toy or applianceFeatures Better than ever digital sound output suitable for almost any environment Interchangeable message grids for one, two, four, or eight messages that support picture symbol overlaysSymbol OverlaysSymbol overlays are not included with the SuperTalker FeatherTouch. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device."

Ablenet, Inc.

2023-06-21

BIG Candy Corn 2 - The BIG Candy Corn 2 accessibility switch uses highly sensitive proximity sensor technology for activation. Anytime the user is near or touching the activation surface, the BIG Candy Corn 2 will activate. Individuals with fine motor impairments or low vision prefer the BIG Candy Corn 2 over the LITTLE Candy Corn because it has an activation surface nearly twice the size.Now powered by 2 AA batteries, the BIG Candy Corn 2 delivers twice the battery life of the original model, ensuring longer-lasting performance. When activated, an auditory beep and light provide feedback, which can be turned off if not needed.

Ablenet, Inc.

2025-06-26

BIGmack - "Start your communication journey with a BIGmack speech device. With a press of the large colored top, an individual can communicate a single message up to 2-minutes long. New messages are easily and quickly recorded to the BIGmack on the fly throughout the day to provide opportunities to communicate in almost any scenario. Includes ableCARE on-demand support Built ableSTRONG to endure drops and other environmental conditions Made from ableSAFE materials and tested by third-party safety labsCommon Uses Request like ""I want"" or ""I need help"" Participate in an activity with ""turn the page"" or ""It's your turn"" Tell your classmates what you did over the weekend during a morning meeting Add communication to a switch controlled toy or appliancegFeatures Better than ever digital sound output suitable for almost any environment Includes red, yellow, green, and blue colored tops Clear snap cover to attach picture symbols and provide communication context to the user Soft-touch coating makes the device easier to holdSymbol OverlaysSymbol overlays are not included with the BIGmack. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device."

Ablenet, Inc.

2023-06-21

58 records. Showing 1-40. Next