510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K160608Substantially Equivalent

NormaTec Pulse and NormaTec Pulse Pro

Normatec Industries, LP, Newton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160608 is the FDA 510(k) clearance record for NormaTec Pulse and NormaTec Pulse Pro, a class II device, cleared for NormaTec Industries, LP on under FDA product code IRP (Massager, Powered Inflatable Tube). FDA records list 9 510(k) clearances for NormaTec Industries, LP, from to . As of , FDA records show no recalls naming K160608.

Clearance record

Decision date
Received
(41 days to decision)
Product code
IRP Massager, Powered Inflatable Tube
Regulation
21 CFR 890.5650
Device class
Class II
Review panel
Physical Medicine
Applicant
NormaTec Industries, LP 44 Glen Ave., Newton MA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code IRP

Trailing 12 months
11 clearances under product code IRP in the twelve months to October 2026, April 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code IRP, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20260
April 20263
May 20262
June 20261
July 20262
August 20261
September 20260
October 20260