DEVICE: NSS MFS (B327NSS202)
Device Identifier (DI) Information
NSS MFS
MFS
In Commercial Distribution
01-1011-NSS/MFS
KEY ELECTRONICS, INC.
MFS
In Commercial Distribution
01-1011-NSS/MFS
KEY ELECTRONICS, INC.
The NSS Military Field Stimulator (MFS) ((510)K140530) is a percutaneous nerve field stimulator (PNFS) system, which is used in a target population of acute and/or chronic pain. The NSS MFS is a battery-operated micro-stimulation appliance weighing approximately 5 grams designed as a disposable product for a single use. The NSS MFS is placed behind the patient’s ear and connected to stimulation needles on the auricle. The NSS MFS offers regular therapy over several days. The appliance transmits low-frequency electric pulses to exposed nerve endings.
Device Characteristics
MR Unsafe | |
No | |
No | |
Yes | |
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? |
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13763 | Acupuncture electrical stimulation system |
An electrically-powered unit designed to be used specifically to apply electrical stimuli to acupuncture sites (electroacupuncture). It is an external low-intensity, low frequency pulse (usually 1 to 100 pulses per second), multimode generator intended to connect to acupuncture electrodes. The electrodes may be placed either on the skin, or through acupuncture needles that penetrate the skin at the acupuncture points. Some may use a probe to detect the acupuncture sites using visual or audio signals.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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BWK | Stimulator, Electro-Acupuncture |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
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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No Device Sizes |
Device Record Status
3b44548c-49b4-438a-b2ec-f2aa8c1534c2
October 23, 2019
3
March 22, 2019
October 23, 2019
3
March 22, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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B327NSS2022 | 20 | B327NSS202 | In Commercial Distribution | ||
B327NSS2021 | 10 | B327NSS202 | In Commercial Distribution | BOX |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined