FDA.report

Z TEK

Primary DI
00860000205191
Brand
Z TEK
Company
Z TECHNOLOGIES LLC
Model
F7
Catalog number
N/A
Device description
TENS DEVICE The device is intended to be used by clinicians in symptomatic relief of chronic intractable pain. Also, for post traumatic and post surgical pain relief.
Published
2018-09-22
Public version status
Update
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

Product Codes

CodeName
GZJStimulator, Nerve, Transcutaneous, For Pain Relief

Product Code Classifications

CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2

Premarket Submissions

SubmissionSupplement
K965244000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K965244000Z TECH TRANSCUTANEOUS NEURAL STIMULATIONZ Technologies, LLC1997-08-27GZJ

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00860000205191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00860000205191008600002051918600002051910860000205191

GMDN Terms

TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered unit 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. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Sterilization Methods

Method

Regulatory Flags

DUNS number
799545652
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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
00086000020514Z TEKF7N/A2018-09-06

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16971712720139KINGPAVONINIHong Qiangxing (Shen Zhen) Electronics LimitedGZJ2026-01-30
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