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Heartway Power Tilt Seating System Power Chair, Model# P16rt
FDA 510(k)Class II (US FDA 510(k))
510(k) K070489
Identifiers
- 510(k) Number
- K070489 FDA 510(k)
- FDA Product Code
- ITI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.3860 FDA 510(k)
- Regulation Number
- 890.3860 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Heartway Power Tilt Seating System Power Chair, Model# P16rt by Heartway Medical Products Co., Ltd. — 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 | K070489 | Class II | Active |
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Manufacturer
- Manufacturer
- Heartway Medical Products Co., Ltd.
Sources (1)
- FDA 510(k) K070489 24 fields · synced Jun 18, 2026