FDA UDI
In Commercial Distribution
🇺🇸 United States
ARMEDICA
DI: B866MAM7131
·
Model: AM713
·
ARMEDICA MANUFACTURING CORP.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- ARMEDICA
- Primary DI
- B866MAM7131
- Version / Model
- AM713
- Catalog Number
- AM713
- Company Name
- ARMEDICA MANUFACTURING CORP.
- Labeler DUNS
- 018941711
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-26
- Public Version
- 1
- Public Version Date
- 2023-06-05
- Public Version Status
- New
- Public Device Record Key
- 5ac7c400-96e7-4cbd-9739-47ce00cef07f
Device Description
STEEL 10 FT SPLIT WOOD PLATFORM MOUNTED MANUAL PARALLEL BARS
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| IOE | Bars, Parallel, Exercise | Physical Medicine | 890.5370 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30926 | Parallel bar exerciser, non-powered | An exercise apparatus designed to assist users in maintaining good walking posture, particularly a person with a disability, a paraplegic, or a patient who has suffered a stroke and is learning to walk. It typically consists of two parallel wooden or steel handrails each one supported by two poles and base plates; the user holds the bars, which may be manually height and width-adjustable, thus relieving his/her weight when walking. The device is intended to improve the user?s balance as well as coordination and flexibility; additionally, it can improve the muscle strength in the lower limbs. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B866PAM7131 | HIBCC | CRATE | 1 | In Commercial Distribution | |
| Primary | B866MAM7131 | HIBCC |