FDA UDI
In Commercial Distribution
🇺🇸 United States
Adjustor
DI: 00858985006155
·
Model: VA3
·
ERCHONIA CORPORATION, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Adjustor
- Primary DI
- 00858985006155
- Version / Model
- VA3
- Catalog Number
- VA3
- Company Name
- ERCHONIA CORPORATION, LLC
- Labeler DUNS
- 004053174
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-19
- Public Version
- 1
- Public Version Date
- 2020-06-29
- Public Version Status
- New
- Public Device Record Key
- ff377b99-9cc7-44fc-9cf9-80f11383f014
Device Description
THERAPEUTIC – Handheld Variable Adjuster – IFU adjunctive use for treatment of symptoms associate with pain
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 |
|---|---|---|---|---|
| 61628 | Circulatory/musculoskeletal vibration therapy unit, platform | A portable, electrically-powered device designed as a standing platform/plate for delivery of therapeutic low-magnitude vibrations throughout the body to improve musculoskeletal structure/function and enhance blood and lymphatic flow. It may be intended as a treatment for osteoporosis or to improve posture, coordination, and balance by using high-frequency, low-intensity mechanical vibrations according to the user’s body mass/dynamics. The device is intended to be used in clinical and home settings. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858985006155 | GS1 |