Power Wheelchair (D39) (K261169): 510(k) cleared for Anhui JBH Medical Apparatus Co., Ltd.
Power Wheelchair (D39) (K261169): 510(k) cleared for Anhui JBH Medical Apparatus Co., Ltd.: 510(k) cleared for Anhui JBH Medical Apparatus Co., Ltd. Its amount of 188 is above the median of 138 (67th percentile). Dated 21 days ago, it is in the active follow-up window. Score 48/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 188 · 67th percentile of 414 FDAPulse records · 1.4x the median
Free preview: all 14 published fields of this record are shown below. Locked: 75 related CN FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261169 |
| Device | Power Wheelchair (D39) |
| Applicant | Anhui JBH Medical Apparatus Co., Ltd. |
| Specialty / panel | Other |
| Product code | ITI |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-04-09 |
| Decision date | 2026-10-14 |
| Review time (days) | 188 |
| Third-party review | No |
| Applicant location | Chuzhou, CN |
| amount percentile | 67th of 414 (median 138, 1.4x median) |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-14
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (CN first): TECAR Therapy Device (TC2000, TC2001) (K252288) · BreathCare PAP III (YH-390N) (K260251) · Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K26023 · Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebuliz · Drainage Catheter (K254179) · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: Power Wheelchair (D39) (K261169): 510(k) cleared for Anhui JBH Medical Apparatus Co., Ltd. and 76 CN peers
- CN FDAPulse records like this one: 76
- Power Wheelchair (D39) (K261169): 510(k) cleared for Anhui JBH Medical Apparatus Co., Ltd.'s amount: 67th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every CN peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
48 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 188-day review, longer than typical.
- Posted 21 days ago.
What is the FDAPulse record for Power Wheelchair (D39) (K261169): 510(k) cleared for Anhui JBH Medical Apparatus Co., Ltd.?
Power Wheelchair (D39) (K261169) by Anhui JBH Medical Apparatus Co., Ltd. was cleared on 2026-10-14 after 188 days of review.
How does Power Wheelchair (D39) (K261169): 510(k) cleared for Anhui JBH Medical Apparatus Co., Ltd. compare to other FDAPulse records?
Its amount of 188 sits in the upper half (67th percentile) of 414 records; the median is 138. It is 21 days old, still within a typical 45-day follow-up window.
Power Wheelchair (D39) (K261169) vs. top 2 peers
| Organization | Location | Record date |
|---|---|---|
| Power Wheelchair (D39) (K261169) | CN | 2026-10-14 |
| Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K260230) | CN | 2026-10-22 |
| Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON) (K260264) | CN | 2026-10-14 |
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