Zhenjiang Assure Mechanical Wheelchair,model:K1— 510(k) K231320
Substantially EquivalentZhenjiang Assure Medical Equipment Co., Ltd.
FDA 510(k) clearance K231320 for Zhenjiang Assure Mechanical Wheelchair,model:K1, Substantially Equivalent on 2023-06-05. Applicant: Zhenjiang Assure Medical Equipment Co., Ltd.. Device class: 1.
Clearance details
- Applicant
- Zhenjiang Assure Medical Equipment Co., Ltd.
- Product code
- Code IOR
- Device class
- Class 1
- Regulation
- 21 CFR 890.3850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Zhenjiang City, CN
Recent devices under product code IOR
view allMore clearances from Zhenjiang Assure Medical Equipment Co., Ltd.
view all- K260319 — K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with swing-away footrest 16 with elevated foot rest(ELR) 18 with elevated foot rest(ELR) 20 with elevated foot rest(ELR))
- K251159 — Power wheelchair
- K232230 — YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE +23 more
- K232198 — Reclining wheelchair (YJ-011S 16D, YJ-011S 16DF, YJ-011S 18D, YJ-011S 18DF, YJ-011S 20D, YJ-011S 20DF)
- K232199 — Bariatric Heavy Duty Wheelchair (YJ-010B 20DS +23 more
Adverse events under product code IOR
product code IOR- Death
- 10
- Injury
- 232
- Other
- 2
- Total
- 244
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.