Identity
- Trade Name
- Invacare Essentials SX3 FDA UDI
- Generic Name
- Push-rim manual wheelchair, non-bariatric FDA UDI
- Device Name
- Essential SX3 16 x 16 Desk Arms Elevating Legrests FDA UDI
- Model / Reference
- ISX366DAEL FDA UDI
- Description
- Essential SX3 16 x 16 Desk Arms Elevating Legrests FDA UDI
Identifiers
- Catalog Number
- ISX366DAEL FDA UDI
- Primary DI / UDI-DI
- 00841447114796 FDA UDI
- 510(k) Number
- K052468 FDA UDI
- FDA Product Code
- IOR FDA UDI
- GMDN Term
- Push-rim manual wheelchair, non-bariatric FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3850 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
Yes
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: Push-rim manual wheelchair, non-bariatric
Invacare Essentials SX3 by Invacare Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Push-rim manual wheelchair, non-bariatric.
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- Probasics — COMPASS HEALTH BRANDS CORP. · Class I
- DALTON WIDE MANUAL WHEELCHAIR — Dalton Medical Corp. · Class I
- DRIVEMEDICAL — Drive Devilbiss Healthcare · Class I
- DRIVEMEDICAL — Drive Devilbiss Healthcare · Class I
- Probasics — COMPASS HEALTH BRANDS CORP. · Class I
- RoughRider — ROUGHRIDER AMERICA LLC · Class I
- JUDITTA — ORMESA SRL · Class I
Cleared under the same submission
K052468 also covers:
- Drive — Drive Devilbiss Healthcare
- Boston Med Center — Dukal LLC
- Tech-Med — Dukal LLC
- Everest & Jennings — GF Health Products, Inc
- Everest & Jennings — GF Health Products, Inc
- Everest & Jennings — GF Health Products, Inc
- Everest & Jennings — GF Health Products, Inc
- Everest & Jennings — GF Health Products, Inc
- Everest & Jennings — GF Health Products, Inc
- Everest & Jennings — GF Health Products, Inc
- Everest & Jennings — GF Health Products, Inc
- Everest & Jennings — GF Health Products, Inc
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Invacare Corp.
Sources (1)
- FDA UDI 52b82544-3ad9-488d-a36e-5f1c2911b2b5 36 fields · synced Jun 8, 2026