FDA UDI
In Commercial Distribution
🇺🇸 United States
PainKARE
DI: 00866946000302
·
Model: PK001
·
TRIOWAVE TECHNOLOGIES
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PainKARE
- Primary DI
- 00866946000302
- Version / Model
- PK001
- Company Name
- TRIOWAVE TECHNOLOGIES
- Labeler DUNS
- 080195601
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-15
- Public Version
- 4
- Public Version Date
- 2019-10-23
- Public Version Status
- Update
- Public Device Record Key
- 1eba2219-f562-436f-ad66-cfa79a583d29
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | Neurology | 882.5890 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35372 | Analgesic transcutaneous electrical nerve stimulation system | An 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00866946000302 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151034 | 000 |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 45 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius