510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963461Substantially Equivalent

Safety Poncho/shoulder Strap Poncho

Skil-Care Corp., Yonkers NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963461 is the FDA 510(k) clearance record for SAFETY PONCHO/SHOULDER STRAP PONCHO, a class I device, cleared for Skil-Care Corp. on under FDA product code KID (Restraint, Wheelchair, Non-Protective). FDA records list 20 510(k) clearances for Skil-Care Corp., from to . As of , FDA records show no recalls naming K963461.

Clearance record

Decision date
Received
(38 days to decision)
Product code
KID Restraint, Wheelchair, Non-Protective
Regulation
21 CFR 890.3910
Device class
Class I
Review panel
Physical Medicine
Applicant
Skil-Care Corp. 167 Saw Mill River Rd., Yonkers NY
510(k) summary
Summary
Third party review
No

Clearances, product code KID

Trailing 12 months

FDA records hold no clearances under product code KID in the trailing twelve months.

FDA records show no clearances under product code KID in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KID, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260