Identity
- Trade Name
- APT PERFORMER FDA UDI
- Generic Name
- Bicycle exerciser FDA UDI
- Device Name
- APT LOWER LIMB TRANING KIT REPAIR PART FDA UDI
- Model / Reference
- 5100D041 FDA UDI
- Description
- APT LOWER LIMB TRANING KIT REPAIR PART FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00092237625729 FDA UDI
- FDA Product Code
- BXB FDA UDI
- GMDN Term
- Bicycle 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bicycle exerciser
Apt Performer by Compass Health Brands Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bicycle exerciser.
- Pedal Exerciser, Folding, Hands/Feet — Dynarex Corp. · Class I
- 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
- Pedal Exerciser, Non-Folding, Hands/Feet — Dynarex Corp. · Class I
- Drive — Drive Devilbiss Healthcare · Class I
- Active Passive Trainer For Upper And Lower Limbs — Guangzhou Pinzhi Medical Technology Co., LTD · Class I
- Drive — Drive Devilbiss Healthcare · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Compass Health Brands Corp.
Sources (1)
- FDA UDI 228520f5-13c8-492f-af2a-44968c65245a 34 fields · synced May 30, 2026