FDA UDI
In Commercial Distribution
🇺🇸 United States
REAL Immersive System
DI: 00815948021037
·
Model: REAL1
·
PENUMBRA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- REAL Immersive System
- Primary DI
- 00815948021037
- Version / Model
- REAL1
- Company Name
- PENUMBRA, INC.
- Labeler DUNS
- 191077671
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-17
- Public Version
- 2
- Public Version Date
- 2021-06-08
- Public Version Status
- Update
- Public Device Record Key
- aeac7402-f0e0-4b06-ade2-27c4d8eaa3f7
Device Description
REAL Immersive System
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| ISD | Exerciser, Measuring | Physical Medicine | 890.5360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60925 | Virtual-display rehabilitation system, non-supportive, clinical | An assembly of devices intended to be used in a clinical setting to provide non-gravity-compensating rehabilitation therapy for neuromuscular/musculoskeletal conditions affecting the back/trunk/limbs (e.g., impaired limb function) through patient interaction with a videogame-like display prompting repeated motion of a body part (e.g., arm, hand, leg) for functional improvement; it may also provide performance feedback. It does not provide weight support and is based on motion-sensing devices [e.g., battery-powered patient-worn infrared (IR) glove, motion tracking heel pad, movement tracking camera, software] that communicate wirelessly to provide a virtual-display interface. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815948021037 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K183296 | 000 |