FDA UDI
In Commercial Distribution
🇺🇸 United States
Erigo
DI: 07629999033894
·
Model: Pro
·
HOCOMA AG
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Erigo
- Primary DI
- 07629999033894
- Version / Model
- Pro
- Catalog Number
- 29673
- Company Name
- HOCOMA AG
- Labeler DUNS
- 487876203
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-03-11
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- d99a1c9e-d263-4887-9adf-f8139f9bf51c
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
- 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 |
|---|---|---|---|---|
| INQ | Table, Powered | Physical Medicine | 890.3760 | 1 |
| BXB | Exerciser, Powered | Physical Medicine | 890.5380 | 1 |
| GZI | Stimulator, Neuromuscular, External Functional | Neurology | 882.5810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42577 | Physical therapy table, line-powered | A mains electricity (AC-powered) device designed for use in physical therapies for mobilization and rehabilitation of neurologically impaired and bedridden patients. It has powered adjustable table functions for height, position and vertical tilting from supine to upright, and typically incorporates foot supports, straps and exercisers (e.g., pulleys or rotators, arm slings, and leg exercisers). It is used during therapeutic exercises and massage typically to enhance blood circulation to the lower limbs in patients with neurological disorders (e.g., spinal cord injury, traumatic brain injury, stroke) and also to aid in muscle training and sense of balance. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07629999033894 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K132416 | 000 |