FDA.report

S-Patch ExL

Primary DI
08800159500022
Brand
S-Patch ExL
Company
Wellysis Corp.
Model
0
Published
2024-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
MWJElectrocardiograph, Ambulatory (Without Analysis)

Product Code Classifications

CodeDeviceSpecialtyClass
MWJElectrocardiograph, Ambulatory (Without Analysis)Cardiovascular2

Premarket Submissions

SubmissionSupplement
K233906000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K233906000S-Patch (S-Patch ExL)Wellysis Corp.2024-02-16DSH

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800159500022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800159500022088001595000228800159500022

GMDN Terms

TermDefinition
Telemetric electrocardiographic ambulatory recorderAn electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be wirelessly transmitted and analysed, typically to a remote computer with a dedicated software located at a medical facility. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).

Sterilization Methods

Method

Contacts

PhoneEmail
+8218002830info@wellysis.com

Regulatory Flags

DUNS number
695705213
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08800159500015S-Patch Ex02023-11-08

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10841522131639Eclipse MiniSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-09-29
10841522131417Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-09-03
10841522131424Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-09-03
04250903200991SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-14
04250903201011SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-14
04250903201035SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-14
04250903200878SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
04250903200892SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
04250903200915SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
04250903201080SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
04250903201103SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
04250903201127SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
00840241600313ASSURE Wearable ECGKestra Medical Technologies, Inc.MWJ2024-09-18
00840241600320Battery Kestra Medical Technologies, Inc.MWJ2024-09-18
00840241600337System CableKestra Medical Technologies, Inc.MWJ2024-09-18
10841522127274Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2024-06-07
10841522129698Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2024-06-07
10841522129728Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2024-06-07
10841522129742Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2024-06-07
10841522129810Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2024-06-07
30841522125557EVOSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2024-04-22
10841522129209Eclipse MiniSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2024-03-19
10841522128769Eclipse MiniSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2024-03-15
B635BIOTRESPR0Biotres ProBIOTRICITY INCMWJ2024-03-07
10841522129674Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2024-02-28
10841522129704Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2024-02-28
10841522129711Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2024-02-28
04250903202636SEER 1000getemed Medizin- und Informationstechnik AGMWJ2023-12-01
04250903202643SEER 1000getemed Medizin- und Informationstechnik AGMWJ2023-12-01
04250903202650SEER 1000getemed Medizin- und Informationstechnik AGMWJ2023-12-01