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Data / Medical devices / United States / Normatec Industries, LP

Normatec Industries, LP: FDA-registered device maker in Watertown, MA, United States, 11 510(k) clearances

Normatec Industries, LP is registered with the FDA (registration 3003619590) in Watertown, MA, United States. It lists 4 device types. The FDA files 11 510(k) clearances under its listings, the newest dated October 6, 2026. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Normatec Industries, LP
FDA registration number
3003619590
Address
480 Pleasant Street, Suite A200, Watertown, MA, United States, 02472
Owner or operator
NORMATEC INDUSTRIES, LP (9048130)
Roles
Specification developer
First device listed
November 27, 2007
Registered through
2027
Brand names listed
Hyperice X, Hyperice X 2, NormaTec MVP, NormaTec PCD, NormaTec Pulse, NormaTec Pulse 2, NormaTec Pulse Pro, NormaTec Pulse Pro 2 and more

Devices it lists

DeviceProduct codeClassRoleSource
Massager, Powered Inflatable TubeIRP2Specification developeraccessdata.fda.gov
Pack, Hot Or Cold, Water CirculatingILO2Specification developeraccessdata.fda.gov
Pad, Heating, PoweredIRT2Specification developeraccessdata.fda.gov
Sleeve, Limb, CompressibleJOW2Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 6, 2026K261887Normatec Elite Heat (PRO26-SH);Normatec Elite Heat (PRO26-ST);Normatec Elite Heat (PRO26-TL);Normatec Elite Heat (PRO26-PH);Normatec Elite Heat (PRO26-PS);Normatec Elite Heat (PRO26-PT)IRPSubstantially EquivalentNormaTec Industries, LPaccessdata.fda.gov
September 18, 2025K251905Normatec Elite HipIRPSubstantially EquivalentNormaTec Industries, LPaccessdata.fda.gov
March 21, 2024K240122Normatec EliteIRPSubstantially EquivalentNormaTec Industries, LPaccessdata.fda.gov
July 14, 2022K221666Normatec GoIRPSubstantially EquivalentNormaTec Industries, LPaccessdata.fda.gov
February 25, 2022K220217Normatec 3IRPSubstantially EquivalentNormaTec Industries, LPaccessdata.fda.gov
December 27, 2018K183169Pulse 2.0, Pulse Pro 2.0IRPSubstantially EquivalentNormaTec Industries, LPaccessdata.fda.gov
December 21, 2018K183328Pulse Rx 2.0, Pulse Pro Rx 2.0JOWSubstantially EquivalentNormaTec Industries, LPaccessdata.fda.gov
June 15, 2016K161346NormaTec PCD-T and PCD-BJOWSubstantially EquivalentNormaTec Industries, LPaccessdata.fda.gov
April 13, 2016K160608NormaTec Pulse and NormaTec Pulse ProIRPSubstantially EquivalentNormaTec Industries, LPaccessdata.fda.gov
January 4, 2012K112890NORMATEC MVPIRPSubstantially EquivalentNormaTec Industries, LPaccessdata.fda.gov
December 21, 2001K013436NORMATEC PCDJOWSubstantially EquivalentNormatec, Inc.accessdata.fda.gov

Compare with other makers

Updated October 6, 2026. 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.