FDA.reportPublic FDA data

NORMATEC INDUSTRIES, LP

Matched from indexed company URL: NormaTec Industries, LP

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30036195903003619590NORMATEC INDUSTRIES, LP1N2026-01-01480 Pleasant Street, Suite A200 Watertown MA US 02472

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
598071720815932K251905Normatec Elite HipIRP2025-09-18
598071441195518K240122Normatec EliteIRP2024-03-21
598071296902548K221666Normatec GoIRP2022-07-14
598071052988225K220217Normatec 3IRP2022-02-25
598071937968629K183328Pulse Rx 2.0, Pulse Pro Rx 2.0JOW2018-12-21
598071333934457K183169Pulse 2.0, Pulse Pro 2.0IRP2018-12-27
598071982136799K161346NormaTec PCD-T and PCD-BJOW2016-06-15
598071070680215K160608NormaTec Pulse and NormaTec Pulse ProIRP2016-04-13
598071139401890K112890NORMATEC MVPIRP2012-01-04
598071438886647K013436NORMATEC PCDJOW2001-12-21
598071554516879
598071648240929

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IRP72025-09-18
JOW32018-12-21

PMN#

GUDID#

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