Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003619590

FEI Number

3003619590

Entity Name

NORMATEC INDUSTRIES, LP

City/State/Country

Watertown, MA, US

Establishment Address

480 Pleasant Street, Suite A200, Watertown, MA 02472, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

NORMATEC INDUSTRIES, LP (Owner Number: 9048130)

Owner / Operator Contact Address

480 Pleasant Street, Suite A200, Watertown, MA 02472, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NormaTec Pulse Pro 2 NormaTec Pulse 2 Normatec 2 Normatec 2 Pro Normatec Elite Hip NormaTec PCD Normatec Elite Normatec 3 NormaTec Pulse Rx 2 NormaTec Pulse Pro Rx 2 Normatec 2 Pro Rx Normatec 2 Rx Hyperice X Hyperice X 2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2019-03-07
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2025-09-19
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2007-11-27
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2024-04-15
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2022-03-21
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2019-03-07
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2021-08-31

Official Correspondent

Gilad JACOBS

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NORMATEC INDUSTRIES, LP

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K242140	Jiale Health Technology Shenzhen Co., Ltd.	Air Compression Leg Massager (K-705)	2025-03-17
K170216	Tactile Systems Technology, Inc. (Dba Tactile Medical)	Flexitouch System	2017-05-26
K100306	Covidien	KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES	2010-05-04
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003619590. Last updated year: 2026. Please use registration number 3003619590 when referencing this establishment in official correspondence.