FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Pedal platform
DI: 07350136560217
·
Model: Pedal Platform
·
Rini Ergoteknik AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pedal platform
- Primary DI
- 07350136560217
- Version / Model
- Pedal Platform
- Catalog Number
- 140-00327-nn
- Company Name
- Rini Ergoteknik AB
- Labeler DUNS
- 354971327
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-24
- Public Version
- 1
- Public Version Date
- 2026-04-01
- Public Version Status
- New
- Public Device Record Key
- 456782f1-e1ce-4732-83ef-0ad88213088d
- Distribution End Date
- 2026-03-24
Device Description
Electrically adjustable pedal platform intended to provide ergonomic foot support for users in clinical environments. The device is designed to be used in conjunction with surgical chairs to improve working posture and comfort. The platform allows height adjustment via electrical control and is intended to support foot positioning and to hold pedals for associated equipment.
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
- 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 |
|---|---|---|---|---|
| GBB | Chair, Surgical, Ac-Powered | General, Plastic Surgery | 878.4960 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37048 | Footrest | A device intended to be used to sustain/retain a patient's foot or feet in a desired position. This device will often be considered an accessory to one or more parent devices. It is typically constructed of metal/plastic/rubber and can be attached to, e.g., operating tables/examination tables/treatment chairs. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07350136560217 | GS1 |