Identity
- Trade Name
- Lelo Tor 2 Purple FDA UDI
- Generic Name
- Penile ring FDA UDI
- Device Name
- External penile rigidity devices are devices intended to create or maintain sufficient penile rigidity for sexual intercourse. External penile rigidity devices include vacuum pumps, constriction rings, and penile splints which are mechanical, powered, or pneumatic devices. FDA UDI
- Model / Reference
- 1885 FDA UDI
- Description
- External penile rigidity devices are devices intended to create or maintain sufficient penile rigidity for sexual intercourse. External penile rigidity devices include vacuum pumps, constriction rings, and penile splints which are mechanical, powered, or pneumatic devices. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350022271838 FDA UDI
- FDA Product Code
- LKY FDA UDI
- GMDN Term
- Penile ring FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5020 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Penile ring
Lelo Tor 2 Purple by Leloi AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Penile ring.
- Quickie Kit — Blush Novelties · Class II
- PERFORMANCE — Blush Novelties · Class II
- Play With Me — Blush Novelties · Class II
- Performance — Blush Novelties · Class II
- Constriction Ring 12mm — KESSEL medintim GmbH · Class II
- Stay Hard — Blush Novelties · Class II
- Performance Plus — Blush Novelties · Class II
- Stay Hard — Blush Novelties · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Leloi AB
Sources (1)
- FDA UDI 3fff85f6-7801-45d2-9c61-c8a19347db82 33 fields · synced May 30, 2026