FDA UDI
In Commercial Distribution
🇺🇸 United States
Alma TED System 120V 50/60HZ
DI: 07290110123567
·
Model: 1
·
ALMA LASERS LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Alma TED System 120V 50/60HZ
- Primary DI
- 07290110123567
- Version / Model
- 1
- Catalog Number
- AATE16112101BA0001
- Company Name
- ALMA LASERS LTD.
- Labeler DUNS
- 532283264
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-15
- Public Version
- 2
- Public Version Date
- 2025-04-04
- Public Version Status
- Update
- Public Device Record Key
- b21723ee-f33f-4ff1-855c-105e7b14543f
Device Description
Alma TED System 120V 50/60HZ
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| ISA | Massager, Therapeutic, Electric | Physical Medicine | 890.5660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40774 | Physical therapy ultrasound system applicator, hand-held | A hand-held component of a physical therapy ultrasound system that includes a transducer designed to convert electric voltages into ultrasound energy [e.g., frequencies greater than 20 kilohertz (kHz)] and directs this energy into body tissues. The localized thermal and nonthermal effects generated by the ultrasonic energy is associated with increased blood flow in the treated area and is intended to accelerate tissue repair. The device is typically used with ultrasound coupling gels to ensure an adequate interface with the patient. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290110123567 | GS1 |