Multi-Mode Stimulator

GUDID 00860019001647

The Elite Medical Supply of NY PMD2000 Multi-Mode Stimulator (MMS) (the Device) is a battery and 110V wall adapter powered electrotherapy devices intended for clinic and outpatient rehabilitative therapy, acute postoperative care and home use for patients suffering from a variety of chronic pain issues. Prescribed by a physician, it gives the clinician a variety of electrotherapy modes to treat a range of indications. The Device is designed for clinician and patient ease of use and provides safe and effective dispensing of the desired electrotherapy treatment. The Intended Use Environment is Home Healthcare but the Device can also be used in a Chiropractic, Physical Therapy or Pain Management Clinic. The Device uses a tactile button user interface for control of the operating system and therapy amplitude settings. The Device has a liquid crystal character display which provides information to the user and displays the current therapy settings. The Device’s therapeutic output is transmitted through the patient lead wires to the cutaneous hydrogel electrodes affixed to the user’s skin. The energy generated by the Device is conveyed, via the patient lead wires and cutaneous electrodes, through the patients skin to excite either the underlying motor nerves to elicit involuntary muscle contractions or the sensory nerves to manage pain.

ELITE MEDICAL SUPPLY OF NY

Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID00860019001647
NIH Device Record Keye46af1a1-20a5-4350-9439-2d4abf26f739
Commercial Distribution StatusIn Commercial Distribution
Brand NameMulti-Mode Stimulator
Version Model NumberPMD2000
Company DUNS608469891
Company NameELITE MEDICAL SUPPLY OF NY
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone716-712-0881
Emailjmcgrady@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjmcgrady@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjmcgrady@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjmcgrady@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjmcgrady@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjmcgrady@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjmcgrady@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjmcgrady@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjmcgrady@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjmcgrady@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjmcgrady@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjmcgrady@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjmcgrady@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjmcgrady@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjmcgrady@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjmcgrady@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjmcgrady@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjmcgrady@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjmcgrady@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjmcgrady@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjmcgrady@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjmcgrady@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjmcgrady@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjmcgrady@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjmcgrady@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjmcgrady@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjmcgrady@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjmcgrady@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjmcgrady@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjnikiel@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjnikiel@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjnikiel@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjnikiel@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjnikiel@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjnikiel@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjnikiel@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjnikiel@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjnikiel@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjnikiel@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjnikiel@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjnikiel@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjnikiel@elitemedicalsupplyofny.com
Phone716-712-0881
Emailjnikiel@elitemedicalsupplyofny.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860019001630 [Primary]
GS100860019001647 [Package]
Contains: 00860019001630
Package: carrying case [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IPFStimulator, Muscle, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-23
Device Publish Date2018-03-19

Devices Manufactured by ELITE MEDICAL SUPPLY OF NY

00860019001623 - Tri-Wave Combination Stimulator2019-10-23 The Elite Medical Supply of NY EMS100 Tri-Wave Combination Stimulator (the Device) is a battery and 110V wall adapter powered el
00860019001647 - Multi-Mode Stimulator2019-10-23The Elite Medical Supply of NY PMD2000 Multi-Mode Stimulator (MMS) (the Device) is a battery and 110V wall adapter powered electrotherapy devices intended for clinic and outpatient rehabilitative therapy, acute postoperative care and home use for patients suffering from a variety of chronic pain issues. Prescribed by a physician, it gives the clinician a variety of electrotherapy modes to treat a range of indications. The Device is designed for clinician and patient ease of use and provides safe and effective dispensing of the desired electrotherapy treatment. The Intended Use Environment is Home Healthcare but the Device can also be used in a Chiropractic, Physical Therapy or Pain Management Clinic. The Device uses a tactile button user interface for control of the operating system and therapy amplitude settings. The Device has a liquid crystal character display which provides information to the user and displays the current therapy settings. The Device’s therapeutic output is transmitted through the patient lead wires to the cutaneous hydrogel electrodes affixed to the user’s skin. The energy generated by the Device is conveyed, via the patient lead wires and cutaneous electrodes, through the patients skin to excite either the underlying motor nerves to elicit involuntary muscle contractions or the sensory nerves to manage pain.
00860019001647 - Multi-Mode Stimulator2019-10-23 The Elite Medical Supply of NY PMD2000 Multi-Mode Stimulator (MMS) (the Device) is a battery and 110V wall adapter powered elect
00860019001654 - 2x4" Rectangle Fabric Electrode2018-11-14 2x4" rectangle white non-woven fabric cutaneous hydrogel electrode, package contains 4 individual electrodes.
00860019001616 - 2" square fabric electrode2018-04-19 2" square white non-woven fabric cutaneous hydrogel electrode, package contains 4 individual electrodes.

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