DEVICE: Impulse EMS D7 (00857771003187)
Device Identifier (DI) Information
Impulse EMS D7
D7
Not in Commercial Distribution
KIMD7
BIOMEDICAL LIFE SYSTEMS, INC.
D7
Not in Commercial Distribution
KIMD7
BIOMEDICAL LIFE SYSTEMS, INC.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
46573 | Physical therapy transcutaneous neuromuscular electrical stimulation system |
An electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
IPF | Stimulator, Muscle, Powered |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K063642 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Width: 2 Inch |
Length: 7 Inch |
Height: 6 Inch |
Device Record Status
51818cef-69ad-4419-a32b-dc6bf22a6d44
June 02, 2023
9
September 23, 2016
June 02, 2023
9
September 23, 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:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
7607275600
information@bmls.com
information@bmls.com