Identity
- Trade Name
- Clevemed FDA UDI
- Generic Name
- Electrode/transducer strap, reusable FDA UDI
- Model / Reference
- 501-0261-1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290013817648 FDA UDI
- 510(k) Number
- K042253 FDA UDI
- FDA Product Code
- MNR FDA UDI
- GMDN Term
- Electrode/transducer strap, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2375 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrode/transducer strap, reusable
Clevemed by S. L. P. Scientific Laboratory Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrode/transducer strap, reusable.
- BRAEBON 1-Foot Double Buckle Effort Belt — Braebon Medical Corp. · Class II
- TONE-A-MATIC — Tone-A-Matic International, Inc. · Class II
- Regard™ — RESOURCE OPTIMIZATION & INNOVATION, L.L.C. · Class I
- Sleepsense — S.L.P. INC.
- Sleepsense — S.L.P. INC.
- ManaMed Transducer Fixation Strap — MANAMED LLC · Class II
- Avazzia — Avazzia, Inc. · Class I
- Natus — S.L.P. INC. · Class II
Cleared under the same submission
K042253 also covers:
- Clevemed — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD
- Embla — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD
- Embla — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD
- Embla — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD
- Embla — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD
- Grass — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD
- Grass — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD
- Grass — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD
- Grass — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD
- Grass — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD
- Neurovirtual — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD
- Neurovirtual — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD
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 |
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Manufacturer
- Manufacturer
- S. L. P. Scientific Laboratory Products Ltd
Sources (1)
- FDA UDI 02f04f3d-1aa6-45ac-9dc0-2a3b5440d164 33 fields · synced May 30, 2026