FDA UDI
In Commercial Distribution
🇺🇸 United States
KBL beautyShaper
DI: 04260489020180
·
Model: T3/50-180-c
·
KBL GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- KBL beautyShaper
- Primary DI
- 04260489020180
- Version / Model
- T3/50-180-c
- Company Name
- KBL GmbH
- Labeler DUNS
- 341936227
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-10
- Public Version
- 1
- Public Version Date
- 2020-12-18
- Public Version Status
- New
- Public Device Record Key
- da5e3934-d5c7-4126-b17d-20b7ff0ef2fa
Device Description
This product is an over-the-counter powered exerciser emitting very bright light.
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 |
|---|---|---|---|---|
| BXB | Exerciser, Powered | Physical Medicine | 890.5380 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58270 | Vibration platform exerciser, stationary | A non-mobile, mains electricity (AC-powered) device designed to generate vertical high-intensity vibrations intended to traverse the body [whole body vibration (WBV)] and cause involuntary muscle contractions to help strengthen/tone muscles and tendons, increase blood flow and joint range of motion, and provide body massage and other health benefits. It consists of a motorized platform/plate, typically with a pole with a digital display/handrails, upon which the user can stand, sit, lay, or apply a specific body part. It may include accessories for specific training (e.g., resistance) and may be used in the home and athletic/clinical settings for rehabilitation or weight loss applications. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260489020180 | GS1 |