FDA UDI
In Commercial Distribution
🇺🇸 United States
Pro Comfort Universal Lumbar Support Back Brace
DI: 00850632007140
·
Model: 62350
·
HOME AIDE DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Pro Comfort Universal Lumbar Support Back Brace
- Primary DI
- 00850632007140
- Version / Model
- 62350
- Catalog Number
- 7140
- Company Name
- HOME AIDE DIAGNOSTICS, INC.
- Labeler DUNS
- 783518983
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-07
- Public Version
- 1
- Public Version Date
- 2018-09-07
- Public Version Status
- New
- Public Device Record Key
- 4086c9ff-8e83-4000-8546-eb47b903cb0e
Device Description
• User for: Postural support, Chronic back pain, Lumbar strains or sprains, Post operative rehabilitation, Lumbar instability • The Pro Comfort Back Brace provides stabilization of the spine and restriction of the pelvis. This, in turn, relieves the pressure on the lumbar discs which helps alleviate pain and increase rehabilitation. • The ergonomic design allows it to be comfortably worn under clothing. • One Size fits all. Adjustable Size
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MRI | Orthosis, Truncal/Orthosis, Limb | Physical Medicine | 890.3490 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41029 | Lumbosacral spine orthosis, hernia/ptosis support | A cloth orthopaedic corset designed to encompass the lumbosacral spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine through abdominal compression, as well as to provide support for abdominopelvic hernias/ptosis. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850632007147 | GS1 | Outer Case | 20 | In Commercial Distribution | |
| Primary | 00850632007140 | GS1 |
Customer Contacts
- Phone
- 18009150116
- [email protected]