Identifiers
- 510(k) Number
- K030869 FDA 510(k)
- FDA Product Code
- KZM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.1375 FDA 510(k)
- Regulation Number
- 890.1375 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BITESTRIP is a disposable electromyographic (EMG) device designed for screening sleep bruxism. It is a Class II medical device with product code KZM, manufactured by S.L.P. Ltd. in Tel Aviv, Israel.
The device is supplied as a single-use product and is authorized under FDA 510(k) clearance K030869, received on March 19, 2003, with a decision date of May 14, 2004. It is regulated under the Physical Medicine specialty and is not indicated for MRI use. The device should be stored according to the manufacturer's instructions.
Frequently asked questions
What is the BITESTRIP device used for?
The BITESTRIP is used for screening sleep bruxism, utilizing electromyographic (EMG) technology to detect and monitor muscle activity.
Is the BITESTRIP device reusable?
No, the BITESTRIP is supplied as a single-use product, ensuring patient safety and preventing cross-contamination.
How should the BITESTRIP device be stored?
The device should be stored according to the manufacturer's instructions to maintain its effectiveness and shelf life.
What regulatory clearance does the BITESTRIP device have?
The BITESTRIP device has received FDA 510(k) clearance, specifically clearance number K030869, indicating substantial equivalence to a predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BITESTRIP (K030869) — FDA 510(k) | Innolitics, BiteStrip — Grokipedia, 510 (k) K030869 — BITESTRIP — RegDataLab, BITESTRIP Trademark of S.L.P. Ltd. - Serial Number 78454714 - Furm
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K030869 | Class II | Active |
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Manufacturer
- Manufacturer
- S.L.P. Ltd.
- FDA Applicant
- S.L.P. , Ltd.
Sources (1)
- FDA 510(k) K030869 24 fields · synced Sep 21, 2026