FDA UDI
In Commercial Distribution
🇺🇸 United States
Joint Jack Company
DI: 00858534005127
·
Model: Dystrophile
·
Joint Jack Company
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Joint Jack Company
- Primary DI
- 00858534005127
- Version / Model
- Dystrophile
- Catalog Number
- 1502
- Company Name
- Joint Jack Company
- Labeler DUNS
- 085068021
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-16
- Public Version
- 1
- Public Version Date
- 2024-01-24
- Public Version Status
- New
- Public Device Record Key
- 5bd04d28-4273-4d47-a984-eccc965be8f8
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
- 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 |
|---|---|---|---|---|
| ION | Exerciser, Non-Measuring | Physical Medicine | 890.5370 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31928 | Hand-held free weight exerciser | A piece of exercise equipment designed primarily to increase muscle strength especially of the upper body by repetitive lifting and lowering with the hands and arms. It may be one of several types of hand-held weights or masses that are not attached to another structural device, including barbells, dumbbells, kettlebells, weight bars, weight plates, and medicine balls. The device is intended to improve strength especially in the arms, wrists, shoulders, chest, and back; it may also be used to help improve lower-body muscle strength and improve body metabolic rate, balance, flexibility, mobility, and bone density. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858534005127 | GS1 |