Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1222630

FEI Number

1000120897

Entity Name

GREGORY MFG., INC.

City/State/Country

Holyoke, MA, US

Establishment Address

102 Cabot St, Holyoke, MA 01040, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

GREGORY MFG., INC. (Owner Number: 9002054)

Owner / Operator Contact Address

102 Cabot ST., --, Holyoke, MA 01040, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Soft Cuff Portable Therapeutix Squid Active Cold Compression device and Cold Pack

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2017-05-18
OED	Antimicrobial Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2013-04-30
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2017-06-09
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2017-06-12
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2014-06-18
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2014-06-18
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2015-11-03

Official Correspondent

WILLIAM GREGORY

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GREGORY MFG., INC.

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
K831001	Frontier Products	UNICUFF-BLOOD PRESSURE CUFF	1983-07-28
K253089	Shenzhen Best Electronics Co., Ltd.	NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)	2026-02-13
K972301	Rudolf Riester GmbH & Co. KG	BIG BEN SQUARE, BIG BEN ROUND	1997-09-17
K071802	Mammendorfer Institut Fur Physik Und Medizin GmbH	TESLA GUARD, MODEL EFT G04	2007-11-09
K124061	Invivo Corporation	MRI PATIENT MONITORING SYSTEM (MODEL 865214)	2013-02-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2015	Invivo Corporation	2	Philips Expression MR200 MRI Patient Monitoring System Model 866120
Z-0004-2023	Philips North America Llc	2	MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
Z-0011-04	GE Medical Systems Information Technologies	2	Power cord manufactured by ElectriCord Manufacturing Company , P/N 316579, used with DINAMAP Patient Monitors as Follows: DINAMAP PRO Series, DINAMAP PRO 1000 Monitor under both the Critikon and GE Medical Systems. The company name EliectriCord is on the power cord plug.
Z-0042-2015	Mckesson Information Solutions LLC	2	McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
Z-2183-2011	Remote Diagnostic Technologies Ltd. The Old Coach House, The Av. Farleigh Wallop, Basingstoke Hampshire United Kingdom	2	TEMPUS IC PROFESSIONAL Patient Monitor, Part No. 00-1002, Manufactured by: Remote Diagnostics Technologies Ltd., The Old Coach House, Farleigh Wallop, Hants, UK RG25 2HT. Indicated for 3 Lead ECG monitoring and 12 Lead ECG recording, non-invasive blood pressure (NIBP), respiration, end-tidal C02 (ETCO 2), pulse oximetry (SP02) and tympanic temperature.

Similar Registrations

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3009154535	WENZHOU KANGSHUN MEDICAL DEVICES CO.,LTD.	Wenzhou City Zhejiang, CN
1058002	Technicuff Corp.	LEESBURG, FL, US
3001570235	GE Medical Systems Information Technologies, Inc.	Waukesha, WI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1222630. Last updated year: 2026. Please use registration number 1222630 when referencing this establishment in official correspondence.