FDA UDI
In Commercial Distribution
🇺🇸 United States
rebless planar
DI: 08800101600169
·
Model: RPLSW
·
H ROBOTICS INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- rebless planar
- Primary DI
- 08800101600169
- Version / Model
- RPLSW
- Company Name
- H ROBOTICS INC.
- Labeler DUNS
- 695126303
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-21
- Public Version
- 1
- Public Version Date
- 2023-08-29
- Public Version Status
- New
- Public Device Record Key
- da34cf17-78f8-4424-a378-575c054e2f16
Device Description
rebless planar is a robotic-assisted upper extremity rehabilitation device that improves motor skills, range of moion, and strength, improving patients overall functional ability.
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
- Yes
- 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 |
|---|---|---|---|---|
| IKK | System, Isokinetic Testing And Evaluation | Physical Medicine | 890.1925 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47517 | Virtual-display rehabilitation system, powered-support, upper-limb | An assembly of devices intended to be used in a clinical setting to provide gravity-compensating rehabilitation therapy for neuromuscular/musculoskeletal conditions affecting the upper limbs (e.g., impaired arm function) through patient interaction with a videogame-like display prompting repeated motion of the limb under treatment (e.g., arm, hand, wrist, shoulder) for functional improvement (e.g., reaching, grasping); it may also provide performance feedback and manual/automatic setting adjustments. It consists of a limb support capable of actively assisting the patient’s movements (e.g., powered robotic arm), and a computer/monitor with software. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800101600169 | GS1 |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 101.3 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 35 – 85 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 30 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 35 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 60 Degrees Celsius