FDA UDI
In Commercial Distribution
🇺🇸 United States
Biometrics Ltd M550 MyoMeter
DI: 05060481690096
·
Model: M550
·
BIOMETRICS LIMITED
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Biometrics Ltd M550 MyoMeter
- Primary DI
- 05060481690096
- Version / Model
- M550
- Company Name
- BIOMETRICS LIMITED
- Labeler DUNS
- 519969810
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-10
- Public Version
- 3
- Public Version Date
- 2018-08-10
- Public Version Status
- Update
- Public Device Record Key
- d3b8e62c-bd22-4ee8-b2f3-f24711cd0288
Device Description
The MyoMeter allows the user to quantify the force applied during Manual Muscle Testing.This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013
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 |
|---|---|---|---|---|
| IKK | System, Isokinetic Testing And Evaluation | Physical Medicine | 890.1925 | 2 |
| ISD | Exerciser, Measuring | Physical Medicine | 890.5360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61672 | Back/leg/chest dynamometer, electronic | A portable, hand-held, electrically-powered, digital instrument designed to assess neuromuscular function by measuring the force or power exerted by the back, chest, and/or leg muscles during flexion. It includes a force gauge, which may be attached to a handle or strap, to assess force generated during a variety of movements (e.g., leg abduction, lifting) and/or force required to be exerted by a clinician to overcome a patient’s resistance (break test techniques). Is typically used to test or control a patient's muscle strength as part of a rehabilitation program. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060481690096 | GS1 |