PainKARE

Primary DI
00866946000302
Brand
PainKARE
Company
TRIOWAVE TECHNOLOGIES
Model
PK001
Device description
PainKARE is an OTC medical device intended to temporarily relieve pain due to strain from exercise or normal household work or activities via electro-therapy. The Device consists two Stimulator pads connected by a USB cable for Electrotherapy.'' PainKARE’s Stimulator pads operate in a programmable micro-current mode and deliver Biphasic waveforms which in turn provide electrical stimulation to the body that aids in relieving pain.
Published
2017-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151034000PainKARETriowave Technologies2015-11-21NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00866946000302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00866946000302008669460003028669460003020866946000302

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic transcutaneous electrical nerve stimulation systemAn assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius45 Degrees Celsius
Storage Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080195601
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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03770018808086actiTENSSUBLIMEDNUH2026-05-27
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