Identity
- Trade Name
- Heavy Duty Clamp complete, Black FDA UDI
- Generic Name
- Wheelchair head/trunk support, prefabricated FDA UDI
- Model / Reference
- 477L52=SK055 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04032767358595 FDA UDI
- FDA Product Code
- KNN FDA UDI
- GMDN Term
- Wheelchair head/trunk support, prefabricated FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3920 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Wheelchair head/trunk support, prefabricated
Heavy Duty Clamp complete, Black by Otto Bock Mobility Solutions GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wheelchair head/trunk support, prefabricated.
- Spex — SPEX LIMITED · Class I
- Spex Limited — SPEX LIMITED · Class I
- Axiom — KI MOBILITY, LLC · Class I
- Axiom — KI MOBILITY, LLC · Class I
- Axiom — KI MOBILITY, LLC · Class I
- Axiom — KI MOBILITY, LLC · Class I
- Axiom — KI MOBILITY, LLC · Class I
- Axiom — KI MOBILITY, LLC · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Otto Bock Mobility Solutions GmbH
Sources (1)
- FDA UDI e984a464-fbc9-4fce-9d9b-6318a5703a75 32 fields · synced Jun 1, 2026