Identity
- Trade Name
- PortableConnect FDA UDI
- Generic Name
- Bicycle exerciser FDA UDI
- Device Name
- The PortableConnect System is a rehabilitative exercise therapy device to increase range of motion FDA UDI
- Model / Reference
- 10100 FDA UDI
- Description
- The PortableConnect System is a rehabilitative exercise therapy device to increase range of motion FDA UDI
Identifiers
- Catalog Number
- 10100 FDA UDI
- Primary DI / UDI-DI
- 00860002828718 FDA UDI
- FDA Product Code
- IKK FDA UDI
- GMDN Term
- Bicycle exerciser FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.1925 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
Yes
FDA UDI
Category: Bicycle exerciser
PortableConnect by ROM Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bicycle exerciser.
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- DRIVEMEDICAL — Drive Devilbiss Healthcare · Class I
- Active Passive Trainer for Upper and Lower Limbs — Guangzhou Longest Science & Technology Co., Ltd. · Class I
- Active Passive Trainer For Upper And Lower Limbs — Guangzhou Pinzhi Medical Technology Co., LTD · Class I
- APT PERFORMER — COMPASS HEALTH BRANDS CORP. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- ROM Technologies, Inc.
Sources (1)
- FDA UDI 44620674-07fd-41dd-9032-ce7ecd18ea18 35 fields · synced Jun 8, 2026