510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K201196Substantially Equivalent

Scooter (Model: FDB01)

Nanjing Jin Bai HE Medical Apparatus Co., Ltd., Nanjing, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201196 is the FDA 510(k) clearance record for Scooter (Model: FDB01), a class II device, cleared for Nanjing Jin Bai HE Medical Apparatus Co., Ltd. on under FDA product code INI (Vehicle, Motorized 3-Wheeled). FDA records list 2 510(k) clearances for Nanjing Jin Bai HE Medical Apparatus Co., Ltd., from to . As of , FDA records show no recalls naming K201196.

Clearance record

Decision date
Received
(417 days to decision)
Product code
INI Vehicle, Motorized 3-Wheeled
Regulation
21 CFR 890.3800
Device class
Class II
Review panel
Physical Medicine
Applicant
Nanjing Jin Bai HE Medical Apparatus Co., Ltd. # 12, Wuge Rd., Jiangning, Nanjing, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code INI

Trailing 12 months
24 clearances under product code INI in the twelve months to October 2026, January 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code INI, trailing twelve months
MonthClearances
November 20251
December 20252
January 20265
February 20262
March 20262
April 20261
May 20261
June 20262
July 20262
August 20262
September 20264
October 20260