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H200 Wireless Hand Rehabilitation System With Optional Intelli-Connect Earpiece…
FDA 510(k)Class II (US FDA 510(k))
510(k) K123636
by Bioness Inc.
Identifiers
- 510(k) Number
- K123636 FDA 510(k)
- FDA Product Code
- GZI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5810 FDA 510(k)
- Regulation Number
- 882.5810 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
H200 Wireless Hand Rehabilitation System With Optional Intelli-Connect Earpiece… by Bioness Inc. — Class II — FDA_510K — listed in FDA 510(k)
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123636 | Class II | Active |
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Manufacturer
- Manufacturer
- Bioness Inc.
- FDA Applicant
- Bioness, Inc.
Sources (1)
- FDA 510(k) K123636 24 fields · synced Jun 18, 2026