FDA UDI
In Commercial Distribution
🇺🇸 United States
MyoCycle Home/Pro
DI: 00861553000400
·
Model: MC-HP-1
·
MYOLYN, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MyoCycle Home/Pro
- Primary DI
- 00861553000400
- Version / Model
- MC-HP-1
- Company Name
- MYOLYN, LLC
- Labeler DUNS
- 078873484
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-04
- Public Version
- 4
- Public Version Date
- 2019-05-23
- Public Version Status
- Update
- Public Device Record Key
- 71187db9-5f8f-46bb-aa17-1efa0e5101dc
Device Description
FES cycle ergometer
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 |
|---|---|---|---|---|
| GZI | Stimulator, Neuromuscular, External Functional | Neurology | 882.5810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46571 | Physical therapy transcutaneous electrical stimulation system, line-powered | An assembly of mains electricity (AC-powered) devices used to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy. It typically includes an electric current pulse generator, electrodes/probes, audible and/or visual indicators, and software. It may provide biofeedback and/or transcutaneous electrical nerve stimulation (TENS) to treat pain. It is typically used to prevent muscle atrophy, for muscle re-education, to relax muscle spasms, to improve blood circulation, for postsurgical calf muscle stimulation to prevent venous thrombosis, and/or to maintain or increase range of motion. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00861553000400 | GS1 |
Customer Contacts
- Phone
- 3523542749
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170132 | 000 |