FDA UDI
In Commercial Distribution
🇺🇸 United States
Auto*Therm 390
DI: 00816864020180
·
Model: ME 390
·
METTLER ELECTRONICS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Auto*Therm 390
- Primary DI
- 00816864020180
- Version / Model
- ME 390
- Catalog Number
- ME 390
- 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
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 0e2fea2e-79fc-487a-85a3-5260b7d5b96b
Device Description
Continuous and pulsed shortwave diathermy with capacitive applicators
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 |
|---|---|---|---|---|
| IMJ | DIATHERMY, SHORTWAVE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT | Physical Medicine | 890.5290 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45207 | Short-wave diathermy treatment system, professional | An assembly of devices designed to provide a therapeutic deep heat within specific volumes of the body through the transcutaneous transmission of electromagnetic (EM) energy in the radio-frequency (RF) bands of 13 megahertz (MHz) to 27.12 MHz. It typically consists of an electric generator and two electrodes (active and return) intended to be held on/near the patient. The device is intended to be operated by healthcare provider in a clinical setting, typically to treat pain, muscle spasms, and joint contractures; it is not used for surgery or to treat malignancies. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816864020180 | GS1 |
Customer Contacts
- Phone
- +1(714)533-2221 ext. 319
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K042554 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 15 | Pound |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Operating Temperture: 50-104 F
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 167 Degrees Fahrenheit