FDA UDI
In Commercial Distribution
🇺🇸 United States
EasyStand
DI: 10858921006109
·
Model: Zing Size 2
·
ALTIMATE MEDICAL INC.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EasyStand
- Primary DI
- 10858921006109
- Version / Model
- Zing Size 2
- Company Name
- ALTIMATE MEDICAL INC.
- Labeler DUNS
- 148515216
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-17
- Public Version
- 2
- Public Version Date
- 2022-08-05
- Public Version Status
- Update
- Public Device Record Key
- 4599a6f7-f5cb-4c2f-bb64-aa21d35737fb
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| INQ | Table, Powered | Physical Medicine | 890.3760 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61701 | Pneumatic stander | A pneumatically-powered device designed to support and lift a disabled (paraplegic) patient to an upright standing position to provide the health benefits associated with standing (e.g., improved breathing, circulation, digestion, and flexibility); it is not intended to facilitate gait. It typically consists of a seat, sling and/or platform with appropriate supports (e.g., footplates, kneepads, chest pad), a compressed gas cylinder, and a pneumatic lifting mechanism to raise the patient from a supine, prone, and/or seated position to standing. It includes wheels for reorientation and may include a manual mechanism to allow the occupant a degree of mobility. | No | Active |
| 61702 | Electric stander | An electrically-powered device designed to support and lift a disabled (paraplegic) patient to an upright standing position to provide the health benefits associated with standing (e.g., improved breathing, circulation, digestion, and flexibility); it is neither intended to facilitate gait nor assist standing transfer. It typically consists of a seat, sling and/or platform with appropriate supports (e.g., footplates, kneepads, chest pad) and an electrically-powered lifting mechanism to raise the patient from a supine, prone, and/or seated position to standing. It includes wheels for reorientation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10858921006109 | GS1 |