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MyoCycle Home/Pro

FDA UDI

Class II (US FDA UDI)

by Myolyn, Inc

Identity

Trade Name
MyoCycle Home/Pro FDA UDI
Generic Name
Physical therapy transcutaneous electrical stimulation system, line-powered FDA UDI
Device Name
FES cycle ergometer FDA UDI
Model / Reference
MC-HP-1 FDA UDI
Description
FES cycle ergometer FDA UDI

Identifiers

Primary DI / UDI-DI
00861553000400 FDA UDI
510(k) Number
K170132 FDA UDI
FDA Product Code
GZI FDA UDI
GMDN Term
Physical therapy transcutaneous electrical stimulation system, line-powered FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5810 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Physical therapy transcutaneous electrical stimulation system, line-powered

MyoCycle Home/Pro by Myolyn, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Physical therapy transcutaneous electrical stimulation system, line-powered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Myolyn, Inc

Sources (1)

  • FDA UDI 71187db9-5f8f-46bb-aa17-1efa0e5101dc 35 fields · synced May 30, 2026