FDA UDI
In Commercial Distribution
🇺🇸 United States
FREEEMG
DI: B179FE3
·
Model: 300
·
BTS SPA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- FREEEMG
- Primary DI
- B179FE3
- Version / Model
- 300
- Catalog Number
- BTSFE3
- Company Name
- BTS SPA
- Labeler DUNS
- 428484518
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-06
- Public Version
- 3
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- 59382963-7338-49b2-ae09-08f45fd3eefa
Device Description
BTS FREEEMG 300 is a wireless surface electromyograph, which makes the selection of muscles, the setting of duration and frequency of acquisition, amplification gain and the correct positioning of electrodes, simple and rapid.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| HCC | Device, Biofeedback | Neurology | 882.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11474 | Electromyograph | An electrically-powered unit designed for the measurement and recording of the intrinsic electrical potential of skeletal muscle for display in the form of a graph [electromyograph (EMG)], typically for diagnosis of muscle and/or nerve disorders. It is designed to receive analogue electrical signals from EMG electrodes and process/digitize these signals for viewing, either on an integrated display or for transmission to an off-the-shelf computer. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B179FE31 | HIBCC | Customized bag | 1 | In Commercial Distribution | |
| Primary | B179FE3 | HIBCC |