FDA UDI
In Commercial Distribution
🇺🇸 United States
Patient Helper
DI: 00670482000821
·
Model: FA64504WG-TRI
·
Umano Medical Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Patient Helper
- Primary DI
- 00670482000821
- Version / Model
- FA64504WG-TRI
- Catalog Number
- FA64504WG-TRI
- Company Name
- Umano Medical Inc
- Labeler DUNS
- 249675476
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-13
- Public Version
- 1
- Public Version Date
- 2024-09-23
- Public Version Status
- New
- Public Device Record Key
- 66d6b2e4-c067-4c59-b825-5971b6c9e8d5
Device Description
A full-body exercise apparatus designed to improve the range of motion around the joints by stretching the major muscle groups in the body using bars.
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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| FNL | Bed, Ac-Powered Adjustable Hospital | General Hospital | 880.5100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11638 | Trapeze bar exerciser | A full-body exercise apparatus designed to improve the range of motion around the joints by stretching the major muscle groups in the body using bars. It may consist of short moveable bars that hang from springs supported by a metal frame installed on a horizontal table, or of trapezoid-like steel bars that hang from chains supported by a metal frame attached to a bed; both assist in stretching exercises of the upper limbs, trunk, and lower limbs, and also help users to change position in bed. The device is mainly intended to improve the flexibility of muscles; it can also increase muscle strength, balance, and coordination, and/or increase cardiovascular endurance. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10670482000828 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 00670482000821 | GS1 |