FDA.reportPublic FDA data

HARMONY

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30101627213010162721HARMONY PLASTICS PRIVATE LTD1N2026-01-01168 Rd No.7 Surat Special Economic Zone Surat Gujarat IN 394230
30376092563037609256HARMONY HEALTH TECH INC1Y2026-01-011414 Sheepshead Bay Rd Ste 102 Brooklyn NY US 11235
30095221343009522134HARMONY HILL INTERNATIONAL CO.,LTD.1N2020-04-257F., No.202, Chongyang Rd., Nangang Dist., Taipei city Taipei - District TW 11573
30106257883010625788HARMONY MEDICAL COMPANY LIMITED1N2020-04-25Unit A, 17/F., Tung Chun Industrial Building Stage 1, Nos 9-11,Cheung Wing Road, Kwai Chung, Hong Kong Hongkong Xianggang CN 523640

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3416741901493867K253919Cryo And Thermo Therapy SystemIRP2026-06-10
3416741155151226K233067Wireless TENS & EMS (Model SM9110,SM9113,SM9116)NUH2024-07-19
3416741248207538K230524Cold Compression Wrap ProIRP2024-01-19
3416741321364566K223825Tens & Ems DeviceNUH2023-05-09
3416741400664135K222098ManaSport+IMI2023-03-08
3416741614612394K210967Air Pressure Therapy System: VU-IPC06IRP2021-05-11
1460291013028815K123076PROFTHAND MECHANICAL WHEELCHAIRIOR2013-08-09
1659461049059158
1480891205559962
1480891528414663
1480891773546372
1460291786165927
1480891891588365
1480891996660608
1659462035961819
3416741241115389
3416741554734129
3416741607471239
3416741626996626
3416741664033578

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IRP32026-06-10
NUH22024-07-19
IMI12023-03-08
IOR12013-08-09

NDC#

PMN#

Applications#