FDA UDI
In Commercial Distribution
🇺🇸 United States
Chair positioning electric
DI: B247PR535
·
Model: PR535
·
GOLDEN BROTHERS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Chair positioning electric
- Primary DI
- B247PR535
- Version / Model
- PR535
- Catalog Number
- PR535
- Company Name
- GOLDEN BROTHERS, INC.
- Labeler DUNS
- 150742401
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-23
- Public Version
- 2
- Public Version Date
- 2022-08-05
- Public Version Status
- Update
- Public Device Record Key
- 6c72fd3e-fdd0-46f0-877b-270f15aa4328
Device Description
Chair positioning electric or lift chair
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| INO | Chair, Positioning, Electric | Physical Medicine | 890.3110 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10796 | Stand-up chair, electric | An electrically-powered device designed to support a patient with a disability (e.g., geriatric, injured, disabled) in a sitting posture and helps the person via its self-raising mechanism to both to sit down from a standing position and stand up from a sitting position. The electrically-powered features may include a seat that can be elevated and tilted forward to help the person stand, and/or a seat composed of several articulated sections that tilt to facilitate the person's activities and comfort. It is neither a stander (which is intended to support a patient in a prolonged standing position) nor a wheelchair. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B247PR535 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K880800 | 000 |