FDA UDI
In Commercial Distribution
🇺🇸 United States
Ovation
DI: 00860009854529
·
Model: ULT
·
Body Balance System, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ovation
- Primary DI
- 00860009854529
- Version / Model
- ULT
- Company Name
- Body Balance System, LLC
- Labeler DUNS
- 876724449
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-18
- Public Version
- 1
- Public Version Date
- 2023-09-26
- Public Version Status
- New
- Public Device Record Key
- 5cf95e82-e23d-41b5-873b-2e3d4c179894
Device Description
The OvationULT is an over-the-counter device that utilizes LED diodes to emit energy in the visible and IR spectrum intended to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and the temporary relaxation of muscles.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating | Physical Medicine | 890.5500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65723 | Red/infrared light phototherapy unit | An electrically-powered device designed to emit red light and infrared/near-infrared light for phototherapy primarily to accelerate healing of cutaneous/mucosal tissues and/or to treat musculoskeletal symptoms (e.g., pain, spasm, stiffness) through modification of cellular metabolism and/or improvement of blood flow. It may have various designs (e.g., hand-held, arched bar, flexible pad for adapting to body areas) and is intended for use in the home and clinical settings. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860009854529 | GS1 |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 50 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 65 – 85 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 65 – 85 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 50 Percent (%) Relative Humidity