FDA UDI
In Commercial Distribution
🇺🇸 United States
Trio*Stim 215
DI: 00816864020401
·
Model: ME 215
·
METTLER ELECTRONICS CORP.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Trio*Stim 215
- Primary DI
- 00816864020401
- Version / Model
- ME 215
- Catalog Number
- ME 215
- Company Name
- METTLER ELECTRONICS CORP.
- Labeler DUNS
- 008513913
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 8
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- 1161f60a-156b-4768-a941-17dc94830b4e
Device Description
Stimulator, nerve, transcutaneous, for pain relief
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GZJ | STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | Neurology | 882.5890 | 2 |
| IPF | Stimulator, muscle, powered | Physical Medicine | 890.5850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46573 | Physical therapy transcutaneous neuromuscular electrical stimulation system | An electrically-powered device assembly 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; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816864020401 | GS1 |
Customer Contacts
- Phone
- +1(714)533-2221 ext. 319
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K990787 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Battery Included | ||
| Weight | 168 | Gram |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 14 – 140 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- No