FDA UDI
In Commercial Distribution
🇺🇸 United States
Harmony SHR™
DI: 00850039266003
·
Model: M1-00001
·
Harmonic Bionics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Harmony SHR™
- Primary DI
- 00850039266003
- Version / Model
- M1-00001
- Catalog Number
- M1-00001
- Company Name
- Harmonic Bionics, Inc.
- Labeler DUNS
- 080508425
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-22
- Public Version
- 1
- Public Version Date
- 2023-06-30
- Public Version Status
- New
- Public Device Record Key
- af32370d-d0d0-46d7-8b22-bcddd887220a
Device Description
Harmony SHR™ is a bilateral upper extremity exoskeleton that works with a patient’s scapulohumeral rhythm (SHR) to enable natural, comprehensive arm and shoulder therapy for those living with neurological and musculoskeletal movement impairments.
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 |
|---|---|---|---|---|
| IKK | System, Isokinetic Testing And Evaluation | Physical Medicine | 890.1925 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48071 | Assistive dynamic arm support system | An assembly of mechanical devices designed to bear the weight of a weak or paralysed arm providing gravity-compensating support for the functional use and/or rehabilitation of the arm/wrist/hand. It is used to support activities of daily life (ADL) such as feeding, self care, computer use, as well as therapeutical training and prevention of complaints of neck and/or shoulder (CANS). It consists of a main column anchored to a surface or wheelchair and a suspended sling or a set of components which take the weight bearing through a set of axes, joints, and a splint underneath the user's arm. Gravity compensation works via a counterweight or spring mechanism and a power-assistive electromotor. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850039266003 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 70 Degrees Celsius