510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K891458Substantially Equivalent

Sw 803 Low Frequency Stimulator Dana Touch

Back in Action, Inc., Mountain View CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K891458 is the FDA 510(k) clearance record for SW 803 LOW FREQUENCY STIMULATOR DANA TOUCH, a class II device, cleared for Back IN Action, Inc. on under FDA product code IPF (Stimulator, Muscle, Powered). FDA records list 2 510(k) clearances for Back IN Action, Inc., from to . As of , FDA records show no recalls naming K891458.

Clearance record

Decision date
Received
(219 days to decision)
Product code
IPF Stimulator, Muscle, Powered
Regulation
21 CFR 890.5850
Device class
Class II
Review panel
Physical Medicine
Applicant
Back IN Action, Inc. P.O. Box 789, Mountain View CA
Third party review
No

Clearances, product code IPF

Trailing 12 months
3 clearances under product code IPF in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IPF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20262
July 20260
August 20260
September 20260
October 20260