DEVICE: Flex Plus (00185098000344)
Device Identifier (DI) Information
Flex Plus
ProM-039
In Commercial Distribution
ProM-039
PRO MEDICAL SUPPLIES, INC.
ProM-039
In Commercial Distribution
ProM-039
PRO MEDICAL SUPPLIES, INC.
Electrodes Black 2.0"x4.0" (1 Pack = 4 Electrodes Per Pack)
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
Yes | |
No | |
Yes | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Transcutaneous electrical stimulation electrode | A non-sterile electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation, cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GXY | Electrode, Cutaneous |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K132998 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
774b004b-d43b-4790-8e1e-9b943cfcf81f
July 06, 2018
3
July 26, 2016
July 06, 2018
3
July 26, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
18509800034404
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
215-938-0200
sales@promedspecialties.com
sales@promedspecialties.com