Identity
- Trade Name
- Relief FDA UDI
- Generic Name
- Orthotic insole, custom-made FDA UDI
- Device Name
- Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare approved inserts. The Relief and Relief+ Custom Orthotic are indicated for Type I Diabetics and Type II Diabetics with pre-ulcerative calluses, poor circulation, diabetics ulcers, previous amputations or partial amputation of either foot. FDA UDI
- Model / Reference
- Insole with Plastizote cover, right FDA UDI
- Description
- Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare approved inserts. The Relief and Relief+ Custom Orthotic are indicated for Type I Diabetics and Type II Diabetics with pre-ulcerative calluses, poor circulation, diabetics ulcers, previous amputations or partial amputation of either foot. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850056031158 FDA UDI
- FDA Product Code
- KYS FDA UDI
- GMDN Term
- Orthotic insole, custom-made FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6280 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
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: Orthotic insole, custom-made
Relief by Solo Laboratories — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthotic insole, custom-made.
- Podoactiva — INSTITUTO DE INVESTIGACION EN ORTOPEDIA AVANZADA SOCIEDAD LIMITADA. · Class I
- Relief+ — SOLO LABORATORIES · Class I
- Relief+ — SOLO LABORATORIES · Class I
- Relief+ — SOLO LABORATORIES · Class I
- Relief — SOLO LABORATORIES · Class I
- Relief+ — SOLO LABORATORIES · Class I
- Relief+ — SOLO LABORATORIES · Class I
- Relief — SOLO LABORATORIES · 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
- Solo Laboratories
Sources (1)
- FDA UDI d51ed747-9cf4-4f40-aa6a-36a3178790d2 34 fields · synced Jun 6, 2026