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OmniCycle Elite 7 Inch Screen Motorized Therapeutic Exercise System

FDA UDI

Class I (US FDA UDI)

by Accelerated Care Plus Corp.

Identity

Trade Name
OmniCycle Elite 7 Inch Screen Motorized Therapeutic Exercise System FDA UDI
Generic Name
Continuous passive motion joint exerciser FDA UDI
Device Name
Motorized therapy cycle with a 7 inch screen that can connect to the OmniTour system FDA UDI
Model / Reference
A007-533 FDA UDI
Description
Motorized therapy cycle with a 7 inch screen that can connect to the OmniTour system FDA UDI

Identifiers

Primary DI / UDI-DI
00858703006399 FDA UDI
FDA Product Code
BXB FDA UDI
GMDN Term
Continuous passive motion joint exerciser FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.5380 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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Continuous passive motion joint exerciser

OmniCycle Elite 7 Inch Screen Motorized Therapeutic Exercise System by Accelerated Care Plus Corp. — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Continuous passive motion joint exerciser.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Accelerated Care Plus Corp.

Sources (1)

  • FDA UDI 1b96ac05-1445-4d02-b2be-ecd27cb01a9c 34 fields · synced May 30, 2026