FDA.reportPublic FDA data

PAI

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
15281611000122747PAIN MANAGEMENT TECHNOLOGIES1Y2026-01-011760 Wadsworth Rd AKRON OH US 44320
30052469583005246958PAIFU COMFORT INDUSTRIAL CO LTD1N2026-01-01No.77, Lane 395,Sec.1 Chung-Cheng N. Rd. Guiren Dist. Tainan City TW 71141
30074391253007439125Pain Care Labs1Y2026-01-01195 ARIZONA AVE LW08 Atlanta GA US 30307
30138198543013819854PAIR EYEWEAR INC HEADQUARTERS1Y2026-01-011935 Deere Avenue Irvine CA US 92606
30171257383017125738PAIGE.AI, INC1N2026-01-0133 Irving Place 3rd Floor New York NY US 10003
30183873153018387315PAIN RELIEF TECHNOLOGIES1N2026-01-018188 S Highland Dr. Suite D1 Sandy UT US 84093
30225183663022518366PainChek Ltd.1N2026-01-01Suite 401, 35 Lime Street Sydney New South Wales AU 2000
30275573343027557334PAINDRAINER AB1N2026-01-01Medicon Village Scheeletorget 1 Lund Skane SE 223 81
30310010983031001098PAIDEX INC.1N2026-01-013330 Bill Metzger Lane Pensacola FL US 32514
30430417223043041722PAINKARE SOLUTIONS inc.1N2026-01-01115 Genevieve Ct Peachtree City GA US 30269
20312093001586040PAINDX1N2020-04-252514 Temple Hills Dr LAGUNA BEACH CA US 92651
30053193353005319335PAINFUL PLEASURES, INC.1N2020-04-257410 Coca Cola Dr. Unit No. 214 Hanover MD US 21076
30127121203012712120PAINPOD USA1Y2020-04-251603 Capitol Ave Suite 310 Cheyenne WY US 82001
30166609243016660924PAIRON SOLUTIONS LLC1Y2020-04-2513970 SW 72ND AVE Portland OR US 97223

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
529341787931908K980866MEDI-DX 7000 CPT WITH AMREX ELECTRODESGWF1998-05-20
529341217284238K964622MEDI-DX 7000LLN1997-12-01
2746912054728780K241273FullFocusQKQ2025-01-09
434371565962081K222770Conductive GelGYB2022-12-13
434371292446078K211263IntreliefNUH2021-12-30
956441267384742K202993Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro); VibraCool® (models: Easy Fit, Extended, Plantar, Flex, Pro DME, Pro UE, Pro LE, Pro 200H)PHW2023-05-15
434371600671819K201196Scooter (Model: FDB01)INI2021-06-25
2746911895102245K201005FullFocusQKQ2020-07-15
434371661303199K143430SmartTENSNUH2015-05-29
434371186162893K142099CUTANEOUS ELECTRODESGXY2014-11-17
434371728451922K140865INFRARED HEATING DEVICEILY2014-09-03
434371647637601K140168EASYSTIM TN28_OTCNUH2014-08-28
1123911090977929K133274VENA PROJOW2014-02-12
434371661148785K132643UV PHOTOTHERAPYFTC2014-01-30
434371116401408K132588ADHESIVE ELECTRODESGXY2013-11-22
956442004864380K130631BUZZYPHW2014-08-13
434371044459242K103719LIFECARE CONDUCTIVE GARMENTSGXY2011-08-24
434371355212207K093138MT9000 SERIES ELECTRO-STIMULATOR, MODELS MT9000, MT9002, MT9001, MT9004 AND MT9003IPF2010-02-12
434371617115496K092627CT2011 SONICSTIMU PAIN RELIEF DEVICEIMG2010-01-14
434371255777608K073386JOINT STIM, MODEL 1000NYN2008-07-30
434371367581595K072256HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODELPFW2008-03-12
434371848303302K050921EASYSTIM NMS-28IPF2005-12-12
434371715874868K040253EASY MED TN-28 CGZJ2004-04-08
434371454108897K032994GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING)GZJ2003-12-16
434371423152233K030375SOFT-TOUCH TENS ELECTRODEGXY2003-05-05
434371604285323K024036PRODUCT LINE-COMBO STIMULATOR/SEQUENTIAL STIMULATOR, MODEL IF-5000IPF2002-12-20
3441821848866423DEN240073PainChek (PainChek Adult)SGB2025-10-06
2746911146359526DEN200080Paige ProstateQPN2021-09-21
1123911101014826
1123911200617408
1123911275268713
1123911280301804
1000121281088475
1123911372118841
1123911421920083
1000121424886035
1000121455372220
1123911573075086
1123911645761869
1123911745506624
1123911756485519
1123911819115618
1123911900982177
1123911913253096
1123912072437345
956441045754372
956441191451322
3186061265751241
1123911425639061
956441445729198
956441447380532
3267351460169530
2103571529984845
956441532329259
2906311569469727
2103571586993444
3186061653472146
2103571740526337
3475741776781244
434371787279960
434371839105723
434371867299478
434371912155639
434371947673867
2103572040729524

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GXY42014-11-17
NUH32021-12-30
IPF32010-02-12
QKQ22025-01-09
PHW22023-05-15
GZJ22004-04-08
SGB12025-10-06
GYB12022-12-13
QPN12021-09-21
INI12021-06-25
ILY12014-09-03
JOW12014-02-12
FTC12014-01-30
IMG12010-01-14
NYN12008-07-30
PFW12008-03-12
GWF11998-05-20
LLN11997-12-01

NDC#

Metoclopramide

PAI Holdings, LLC dba PAI Pharma

metoclopramide hydrochloride

GUAIFENESIN DM

PAI Holdings, LLC dba PAI Pharma

GUAIFENESIN and DEXTROMETHORPHAN

TRICITRATES

PAI Holdings, LLC dba PAI Pharma

POTASSIUM CITRATE, SODIUM CITRATE, and CITRIC ACID MONOHYDRATE

Fluoxetine

PAI Holdings, LLC dba PAI Pharma

FLUOXETINE HYDROCHLORIDE

SULFATRIM

PAI Holdings, LLC dba PAI Pharma

Sulfamethoxazole and Trimethoprim

Nystatin

PAI Holdings, LLC dba PAI Pharma

NYSTATIN

LACTULOSE

PAI Holdings, LLC dba PAI Pharma

Lactulose

Phenytoin

PAI Holdings, LLC dba PAI Pharma

Phenytoin

141 records. Showing 1-40. Next

PMN#

Applications#