510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K942184Substantially Equivalent

Clinitron at Home Air Fluided Therapy

Ssi Medical Services, Inc., Charleston SC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K942184 is the FDA 510(k) clearance record for CLINITRON AT HOME AIR FLUIDED THERAPY, a class II device, cleared for Ssi Medical Services, Inc. on under FDA product code INX (Bed, Air Fluidized). FDA records list 6 510(k) clearances for Ssi Medical Services, Inc., from to . As of , FDA records show 2 recalls naming K942184.

Clearance record

Decision date
Received
(279 days to decision)
Product code
INX Bed, Air Fluidized
Regulation
21 CFR 890.5160
Device class
Class II
Review panel
Physical Medicine
Applicant
Ssi Medical Services, Inc. 4349 Corporate Rd., Charleston SC
510(k) summary
Statement
Third party review
No

Clearances, product code INX

Trailing 12 months

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

FDA records show no clearances under product code INX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code INX, 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